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Hydrocodone Bitartrate and Homatropine Methylbromide

Hydrocodone Bitartrate and Homatropine Methylbromide · HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.

NDC 43386-0118-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. The price has held steady around $0.9864 per unit over the past year.

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

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$0.5$1.00$1.50Dec 2014Mar 2024$0.9864
105 price points · per · last surveyed Invalid DateSource: CMS NADAC

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 homatropine methylbromide (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
ANDA091528
TE code
Approval date
Apr 20, 2011
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedMar 5, 2018
    Novel Laboratories, Inc.Failed Impurities/Degradation Specifications

Manufacturers of Hydrocodone Bitartrate and Homatropine Methylbromide (Tablet)

LabelerStrengthFirst seenLast seen
Genus Lifesciences Inc.HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1Aug 26, 2026Sep 2, 2026
KVK-Tech, Inc.HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1Aug 26, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1Aug 26, 2026Sep 2, 2026
Novel Laboratories, Inc.HYDROCODONE BITARTRATE 5 mg/1; HOMATROPINE METHYLBROMIDE 1.5 mg/1Aug 26, 2026Sep 2, 2026
Genus Lifesciences Inc.HYDROCODONE BITARTRATE 1.5 mg/1; HOMATROPINE METHYLBROMIDE 5 mg/1Jul 22, 2026Aug 19, 2026
KVK-Tech, Inc.HYDROCODONE BITARTRATE 1.5 mg/1; HOMATROPINE METHYLBROMIDE 5 mg/1Jul 22, 2026Aug 19, 2026
Lupin Pharmaceuticals,Inc.HYDROCODONE BITARTRATE 1.5 mg/1; HOMATROPINE METHYLBROMIDE 5 mg/1Jul 22, 2026Aug 19, 2026
Novel Laboratories, Inc.HYDROCODONE BITARTRATE 1.5 mg/1; HOMATROPINE METHYLBROMIDE 5 mg/1Jul 22, 2026Aug 19, 2026
Genus Lifesciences Inc.HOMATROPINE METHYLBROMIDE 1.5 mg/1; HYDROCODONE BITARTRATE 5 mg/1Jul 15, 2026Jul 15, 2026
KVK-Tech, Inc.HOMATROPINE METHYLBROMIDE 1.5 mg/1; HYDROCODONE BITARTRATE 5 mg/1Jul 15, 2026Jul 15, 2026
Lupin Pharmaceuticals,Inc.HOMATROPINE METHYLBROMIDE 1.5 mg/1; HYDROCODONE BITARTRATE 5 mg/1Jul 15, 2026Jul 15, 2026
Novel Laboratories, Inc.HOMATROPINE METHYLBROMIDE 1.5 mg/1; HYDROCODONE BITARTRATE 5 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Hydrocodone Bitartrate and Homatropine Methylbromide — NDC 43386-0118-01," retrieved September 3, 2026, https://drugdashboards.com/drug/43386011801.

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