DrugDashboards

Hydrocodone Bitartrate and Homatropine Methylbromide

hydrocodone bitartrate and homatropine methylbromide oral solution · HYDROCODONE BITARTRATE 5 mg/5mL; HOMATROPINE METHYLBROMIDE 1.5 mg/5mL · Liquid · Oral · KVK-Tech, Inc.

NDC 10702-0150-16 · 473 mL in 1 BOTTLE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $0.1031 per mL 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: worth watching — several of the pressures that precede supply trouble are present at once.

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

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

  • Pharmacies pay (NADAC)$0.1031per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicaid generic ceiling (FUL)$0.0980per MLweighted avg manufacturer price $0.0508 · Feb 1, 202695% of what pharmacies pay — a deeper discount than 95% of drugs with this benchmark

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$0.1$0.2$0.3Oct 2017Sep 2026$0.1031
108 price points · per ML · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Medicaid spend (2025)

$31,897
2,094 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30● Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

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 (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · price up 8% YoY

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
ANDA207487
TE code
AA
Approval date
Feb 21, 2017
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedNov 1, 2019
    KVK-Tech, Inc. — Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

Manufacturers of hydrocodone bitartrate and homatropine methylbromide oral solution (Liquid)

LabelerStrengthFirst seenLast seen
KVK-Tech, Inc.HYDROCODONE BITARTRATE 5 mg/5mL; HOMATROPINE METHYLBROMIDE 1.5 mg/5mLAug 26, 2026Sep 2, 2026
KVK-Tech, Inc.HYDROCODONE BITARTRATE 1.5 mg/5mL; HOMATROPINE METHYLBROMIDE 5 mg/5mLJul 22, 2026Aug 19, 2026
KVK-Tech, Inc.HOMATROPINE METHYLBROMIDE 1.5 mg/5mL; HYDROCODONE BITARTRATE 5 mg/5mLJul 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 10702-0150-16," retrieved September 3, 2026, https://drugdashboards.com/drug/10702015016.

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