DrugDashboards

Glycopyrrolate

Glycopyrrolate · GLYCOPYRROLATE .2 mg/mL · Injection, Solution · Intramuscular; Intravenous · ProPharma Distribution

NDC 84549-0204-42 · 5 mL in 1 VIAL, GLASS · ANDA · View full market →

The short version

11 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.

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
ANDA210842
TE code
AP
Approval date
Oct 25, 2018
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation — Glycopyrrolate, Injection, .2 mg/1 mL (NDC 63323-578-01)Jul 30, 2026
  • Planned discontinuation — Glycopyrrolate, Injection, 0.2 mg per 1 mL (NDC 65219-801-01)Jul 30, 2026
  • Planned discontinuation — Glycopyrrolate, Injection, 0.4 mg per 2 mL (NDC 63323-578-02)Jul 30, 2026
  • Planned discontinuation — Glycopyrrolate, Injection, 1 mg per 5 mL (NDC 63323-578-05)Jul 30, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Glycopyrrolate (Injection, Solution)

LabelerStrengthFirst seenLast seen
American Regent, Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
AuroMedics Pharma LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Exela Pharma Sciences, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Henry Schein, Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Medical Purchasing Solutions, LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Piramal Critical Care IncGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
ProPharma DistributionGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 3, 2026
Civica, Inc.GLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsGLYCOPYRROLATE .2 mg/mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCGLYCOPYRROLATE .2 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Glycopyrrolate — NDC 84549-0204-42," retrieved September 3, 2026, https://drugdashboards.com/drug/84549020442.

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