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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 · KVK-Tech, Inc.

NDC 10702-0055-03 · 30 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 $0.9434 per unit over the past year. One of its named manufacturing plants, Kvk-Tech, Inc., failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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$1.50Apr 2018Sep 2026$0.9434
97 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$28.30
#90 count
$84.91

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Supply fragility

5Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 4 active manufacturers+5

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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
ANDA207176
TE code
AA
Approval date
Aug 7, 2017
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedApr 27, 2021
    KVK-Tech, 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 10702-0055-03," retrieved September 3, 2026, https://drugdashboards.com/drug/10702005503.

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