DrugDashboards

Glycopyrrolate

Glycopyrrolate · GLYCOPYRROLATE .2 mg/mL · Injection, Solution · Intramuscular · Henry Schein, Inc.

NDC 00404-9782-02 · 1 VIAL, SINGLE-DOSE in 1 BAG / 1 mL in 1 VIAL, SINGLE-DOSE · 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.

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.

Medicare Part B (ASP)

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

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 →

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 00404-9782-02," retrieved September 3, 2026, https://drugdashboards.com/drug/00404978202.

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