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Glycopyrrolate

NDC 63323-578 · Fresenius Kabi USA, LLC

FDA carries 2 listing records for this NDC; the most recent is shown.

Generic nameGlycopyrrolate
Dosage formINJECTION, SOLUTION
RouteINTRAMUSCULAR, INTRAVENOUS
Active ingredient(s)GLYCOPYRROLATE
Strength.2 mg/mL
Pharmacologic classAnticholinergic [EPC], Cholinergic Antagonists [MoA]
Marketing categoryANDA

Packages

63323-578-01 — 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03)

63323-578-02 — 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04)

63323-578-05 — 25 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07)

63323-578-11 — 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-11) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-41)

63323-578-12 — 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-12) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-42)

Billed under HCPCS

J1596 — Injection, glycopyrrolate, 0.1 mg Medicare Part B payment limit (ASP + 6%): $0.36

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

59651-435 — GLYCOPYRROLATE, 60429-666 — GLYCOPYRROLATE, 60687-458 — GLYCOPYRROLATE, 62135-734 — Glycopyrrolate, 62135-735 — Glycopyrrolate, 62135-961 — Glycopyrrolate, 62332-607 — Glycopyrrolate, 62332-627 — Glycopyrrolate, 62332-628 — Glycopyrrolate, 62332-629 — Glycopyrrolate, 63629-2206 — glycopyrrolate, 63629-2207 — glycopyrrolate, 63629-7207 — GLYCOPYRROLATE, 63629-9287 — glycopyrrolate, 63629-9592 — Glycopyrrolate, 65145-102 — Glycopyrrolate, 65145-103 — Glycopyrrolate, 65145-104 — Glycopyrrolate, 65145-105 — Glycopyrrolate, 65219-801 — Glycopyrrolate, +177 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.