Shortage injectables: FDA approvals against products listed for sale

For dopamine, the FDA has approved 37 applications under 15 applicant names. 4 of the approvals have an active listing, under 3 of the names. For carboplatin, 9 of 37 approvals have a listing, under 8 of 26 names. Meperidine has 31 approvals and 2 with a listing. Promethazine has 20 approvals, 15 names, and 2 approvals with a listing.

6 of the 49 drugs have one applicant name or none with a listing: conivaptan hydrochloride; epinephrine bitartrate and lidocaine hydrochloride; penicillin G benzathine; pentostatin; sufentanil citrate; triamcinolone hexacetonide.

An approval that covers more than one drug on the list counts as listed when any of its drugs has an active listing. 5 approvals count as listed only through labelers whose FDA establishment registrations show only repack or relabel operations. 53 of the 157 labelers have no registration that we could match by name, so that count is a floor.

Presentations are the rows on the FDA list: one per company, strength and package. Applicant names are as the Orange Book gives them; one company can hold approvals under several names. Labelers are the companies that list a product under one of the approvals. They include repackagers and relabelers, so a drug can have more labelers than applicant names.

Medicare Part B sets a payment limit for each drug billing code, per billing unit, every quarter (CMS payment limit file, October 1 to December 31, 2026, based on 2Q26 sales data). It is what Part B allows when it pays for the drug separately. CMS assigns each NDC to a code in its NDC to HCPCS crosswalk. Through the NDCs listed under the approvals above, 30 of the 49 drugs map to 38 codes. The other 19 have no code with a limit in this file.

For the insurers, we used the standard-charge files that 8 adult Dallas-Fort Worth hospitals publish under 45 CFR 180: commercial plans of the 4 insurers Blue Cross Blue Shield of Texas, UnitedHealthcare, Aetna and Cigna, outpatient, the same files as Wellness 005. A hospital lists most drugs per vial or bag. Where the description states the dose in the item, we divided the rate by the billing units in it. Where the file lists the code's own descriptor, the rate is already per billing unit. Medians run plan, then hospital, then hospital system, then over system and insurer pairs.

We left out preparations that are unlike the coded product: descriptions with the words intravitreal, ophthalmic, intracameral, intraocular, irrigation, flush, lock, compounded or cardioplegia; items of 0.1 mL or less; and unit-dosed solutions of 2 units per mL or less, such as line flush bags (84 rows, each one in the excluded rows file).

33 codes have insurer rates from at least 2 hospital systems. The insurer median per billing unit is at or above the Medicare limit for 32 of 33 codes, and above it for 31. The median ratio is 2.96. The code below the limit: J1643 (heparin sodium). The range runs from 0.85 (heparin sodium, J1643) to 23.05 (azacitidine, J9025). For ketorolac (J1885, per 15 mg), Medicare allows $0.57 and the insurer median is $2.37. These are prices that the insurers agreed with the hospitals. They are not what a patient pays, and they are not the hospital's cost.

One rule is one-sided. We drop rows below 0.25 times the Medicare limit per unit as unit errors, and we have no upper cutoff, because a hospital rate can be many times the limit. With the low rows kept, the insurer median is at or above the limit for 32 of 33 codes and above it for 31, and the median ratio is 2.94.

5 more codes for these drugs have a Medicare limit but insurer rates from fewer than 2 hospital systems in these files. They are not in the comparison.

Without liraglutide, Medicaid paid $429.3 million for these drugs in 2025, across 6,154,912 claims (State Drug Utilization Data 2025, all states and both programs). The field is Total Amount Reimbursed. The CMS field descriptions (file dated December 4, 2019) define it as not reduced by rebates and inclusive of dispensing fees. It includes what other payers on the claim paid.

Liraglutide is a pen that pharmacies dispense, not a hospital injectable, so we give it apart: Medicaid paid $143.9 million for it in 2025, across 259,010 claims. With it, the total is $573.3 million across 6,413,922 claims.

We do not compare Medicaid per billing unit. States report units per NDC in a unit type that the public file does not carry. For the same NDC, the units per claim that states report differ by a factor of 10 or more for 380 of the 599 NDCs that at least 5 states report. The file cannot tell a large fill from a different unit. The table gives the totals.

The table lists 44 of the 49 drugs. The other 5 have $0 paid and 0 claims in the rows this page counts: Conivaptan Hydrochloride; Pentostatin; Propranolol Hydrochloride; Technetium Tc 99m Pyrophosphate Kit; Triamcinolone Hexacetonide.

A common claim is that shortages hit the generic injectables with the lowest prices. We tested one version of it with the Medicare limit for one item: the limit per billing unit times the billing units in one vial, bag or syringe, the median over the NDCs that CMS assigns to the code.

The 38 codes for the shortage drugs have a median limit of $5.32 per item. The 253 other drug codes (J codes) that include an NDC listed under a generic approval (ANDA) have a median of $15.74. 26 of the 38 shortage codes are below that median. A rank test (Mann-Whitney) gives p = 0.009. In this data, the shortage injectables sit at lower Medicare limits per item than other generic injectables. This shows an association. It does not show that a low price causes a shortage.

Cost Plus Drugs built a plant in Dallas to make sterile injectables. On April 3, 2024, Entrepreneur reported: "Mark Cuban Cost Plus Drug Co. is sending out its first batch of allergy medication, epinephrine, and blood pressure drug, norepinephrine, to 10 hospitals in Texas and Pennsylvania." It added: "Both drugs face nationwide shortages and Cost Plus began producing them at its Dallas facility last month, according to Bloomberg." (Entrepreneur, April 3, 2024). These are past reports. This page does not know what the plant makes today.

On the FDA list, no epinephrine injection and no norepinephrine injection has the status Current. Epinephrine Injection has the status To Be Discontinued. Two combinations that contain epinephrine, bupivacaine with epinephrine and lidocaine with epinephrine, are in shortage.

Cost Plus also sells to businesses through the Cost Plus Marketplace. Its catalog needs a business login, so this page cannot cite it. In April 2025, the distributor Morris & Dickson announced a partnership with Cost Plus to distribute injectable drugs through the Marketplace (Morris & Dickson).

This page does not say which of these drugs Cost Plus makes or sells, or could make or sell.

The Medicaid amounts are before rebates. Under federal law, drug makers pay Medicaid rebates (Social Security Act, section 1927). The amounts include dispensing fees and what other payers on the claim paid.

The Medicare limit is a cap on what Part B allows when it pays a drug separately. It is not what a hospital receives for every dose. The insurer rates are what each hospital's file lists for the insurers' commercial plans. A file can list a rate that a plan rarely pays.

For the hospital rates, we also left out rows with no dollar (129), rows the file marks as paid for no claims (4,576), rows the file marks as bundled or not paid separately (942), rows whose description does not state the dose in the item (4,012), and codes billed by volume (343). The low cutoff set aside 367 rows. A fee schedule row can be per item or per billing unit, and not every file says which. We read it as per item, as the description states.

The NDC Directory lists products. It does not show how much a company makes or ships. An approval can be held by a company that sold the product line, and a listing can stay active after a company stops shipping. No public FDA file links a drug to the plant that makes it, so this page names no plant for any drug.

This page does not grade any company, insurer, hospital or program.

• FDA Drug Shortages through the openFDA shortages endpoint, read on November 4, 2026: every row with status Current and dosage form Injection. The latest update for these drugs is October 29, 2026; for the whole list, October 30, 2026.
• Orange Book data files, September 2026 edition: every ANDA and NDA for the same ingredient, in an injectable form. A combination matches only the same combination. Dextrose matches by strength. Approvals in the Orange Book's discontinued section count as approvals, and the page gives them apart.
• NDC Directory, file of November 4, 2026: a listing counts when its application number is one of the approvals and its marketing has not ended.
• Medicare Part B ASP files for October 1 to December 31, 2026: the payment limit file and the NDC to HCPCS crosswalk.
• State Drug Utilization Data 2025: every row for the NDCs listed under the approvals or named on the shortage list. The national total rows (state XX) and suppressed rows are left out.
• FDA establishment registrations (DECRS), through the public API, for the labelers that list these approvals.
• Hospital standard-charge files, the same pull as Wellness 005:
  • Baylor University Medical Center (Baylor Scott & White), file dated June 29, 2026
  • Texas Health Presbyterian Dallas (Texas Health Resources), file dated April 21, 2026
  • Texas Health Harris Methodist Fort Worth (Texas Health Resources), file dated April 21, 2026
  • Methodist Dallas (Methodist Health System), file dated March 20, 2026
  • Parkland (Parkland), file dated October 16, 2026
  • UT Southwestern Clements (UT Southwestern), file dated March 10, 2026
  • Medical City Dallas (Medical City (HCA)), file dated September 1, 2026
  • JPS Health Network (JPS Health Network), file dated April 1, 2026