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Glycopyrrolate

glycopyrrolate · GLYCOPYRROLATE .2 mg/mL · Injection · Intramuscular; Intravenous · Accord Healthcare, Inc.,

NDC 16729-0474-03 · 10 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE · ANDA · View full market →

The short version

24 companies supply this market — deep enough that no single failure threatens the supply. Historically, drugs in this position went on to a new shortage within 90 days about 0.5% of the time — roughly 4× the typical drug (0.1%).

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

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

Estimated fill cost

WAC per package, as filed
$399.00
Reported to Texas DSHS · 2024 annual filing · Accord Healthcare, Inc

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

Supply fragility

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

90-day shortage risk (model v2)

0.5%chance of a new FDA shortage posting for glycopyrrolate (injectable) in the next 90 days

sterile injectable · 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 4× that.

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
ANDA213238
TE code
AP
Approval date
Jul 8, 2020
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedFeb 7, 2023
    Accord Healthcare, Inc. — CGMP Deviations: recalling drug products following an FDA inspection.
  • Class II · TerminatedFeb 7, 2023
    Accord Healthcare, Inc. — CGMP Deviations: recalling drug products following an FDA inspection.
  • Class II · TerminatedFeb 7, 2023
    Accord Healthcare, Inc. — CGMP Deviations: recalling drug products following an FDA inspection.
  • Class II · TerminatedFeb 7, 2023
    Accord Healthcare, Inc. — CGMP Deviations: recalling drug products following an FDA inspection.
  • Class III · TerminatedJan 28, 2021
    Accord Healthcare, Inc. — Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

Manufacturers of glycopyrrolate (Injection)

LabelerStrengthFirst seenLast seen
Accord Healthcare, Inc.,GLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Gland Pharma LimitedGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
HF Acquisition Co LLC, DBA HealthFirstGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Hikma Pharmaceuticals USA Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Medical Purchasing Solutions, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Solco Healthcare US, LLCGLYCOPYRROLATE .4 mg/2mLJul 15, 2026Sep 3, 2026
Solco Healthcare US, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Somerset Therapeutics, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Xiromed LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Xiromed, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Amneal Pharmaceuticals LLCGLYCOPYRROLATE 4 mg/20mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCGLYCOPYRROLATE .4 mg/2mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
BE Pharmaceuticals Inc.GLYCOPYRROLATE 4 mg/20mLJul 15, 2026Sep 2, 2026
BE Pharmaceuticals Inc.GLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
BE Pharmaceuticals Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
BE Pharmaceuticals Inc.GLYCOPYRROLATE .4 mg/2mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedGLYCOPYRROLATE 4 mg/20mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedGLYCOPYRROLATE .4 mg/2mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Civica, Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Jvet Pharmaceuticals LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Sandoz IncGLYCOPYRROLATE 4 mg/20mLJul 15, 2026Sep 2, 2026
Sandoz IncGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Sandoz IncGLYCOPYRROLATE .4 mg/2mLJul 15, 2026Sep 2, 2026
Sandoz IncGLYCOPYRROLATE 1 mg/5mLJul 15, 2026Sep 2, 2026
Xiromed LlcGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Aug 31, 2026
Meitheal Pharmaceuticals Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Aug 31, 2026
Nivagen Pharmaceuticals, Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Aug 31, 2026
Fresenius Kabi USA, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Aug 29, 2026
Alembic Pharmaceuticals Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Aug 28, 2026
Medical Purchasing Solutions, LLCGLYCOPYRROLATE 4 mg/20mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Glycopyrrolate — NDC 16729-0474-03," retrieved September 3, 2026, https://drugdashboards.com/drug/16729047403.

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