DrugDashboards

Hydrocodone Bitartrate and Acetaminophen

Hydrocodone Bitartrate and Acetaminophen · HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1 · Tablet · Oral · Asclemed USA, Inc.

NDC 76420-0215-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

15 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00406-0125-05) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of saleⓘ
$0.2248per unit
middle half $0.1861–$0.3445 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.2248
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 3 · prior auth 2% · step therapy 0% · qty limit 96%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for hydrocodone bitartrate and acetaminophen (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA202991
TE code
AA
Approval date
Apr 12, 2016
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Hydrocodone Bitartrate and Acetaminophen (Tablet)

LabelerStrengthFirst seenLast seen
Asclemed USA, Inc.HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Asclemed USA, Inc.HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Proficient Rx LPHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
SpecGx LLCHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 20, 2026Sep 3, 2026
St. Mary's Medical Park PharmacyHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
XLCare Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
XLCare Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
XLCare Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
XLCare Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 2.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
A-S Medication SolutionsHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
American Health PackagingHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
American Health PackagingHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
American Health PackagingHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
AvPAKHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
AvPAKHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
AvPAKHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 2.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Cranbury Pharmaceuticals, LLCHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Cranbury Pharmaceuticals, LLCHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Hydrocodone Bitartrate and Acetaminophen — NDC 76420-0215-01," retrieved September 3, 2026, https://drugdashboards.com/drug/76420021501.

Free to cite with attribution — see how the data is put together.