DrugDashboards

Glycopyrrolate

Glycopyrrolate · GLYCOPYRROLATE .2 mg/mL · Solution · Intramuscular; Intravenous · Somerset Therapeutics, LLC

NDC 70069-0618-25 · 25 VIAL in 1 CARTON / 2 mL in 1 VIAL · ANDA · View full market →

The short version

13 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Somerset Therapeutics Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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.

  • Medicare Part B pays (ASP+6%)$0.3650per billing unit (0.1 MG)HCPCS J1596 · Jul 1, 2026
  • Part D plans paid (avg)$0.9615per dosage unitgross, before rebates — matched by drug name · 2024

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

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

Estimated fill cost

WAC per package, as filed
$99.75
Reported to Texas DSHS · 2026 annual filing · Somerset Therapeutics, LLC

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 0.1 MG
$0.365
HCPCS J1596 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$2,796
65 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for glycopyrrolate (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · 1 Class I/II recall(s) in 12 months

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 · avg $42.13 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA207639
TE code
AP
Approval date
Jun 23, 2017
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 Glycopyrrolate (Solution)

LabelerStrengthFirst seenLast seen
Somerset Therapeutics, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Ajenat Pharmaceuticals LlcGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Atlantic Biologicals Corp.GLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Bionpharma Inc.GLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.GLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Chartwell RX, LLCGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Granules Pharmaceuticals Inc.GLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
NorthStar RxLLCGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Par Health USA, LLCGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Precision Dose, Inc.GLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Saptalis Pharmaceuticals, LLC.GLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Glycopyrrolate — NDC 70069-0618-25," retrieved September 3, 2026, https://drugdashboards.com/drug/70069061825.

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