NDC 76045-203

Glycopyrrolate

Glycopyrrolate

Glycopyrrolate is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Glycopyrrolate.

• Product ID: 76045-203_268b94e2-6d4d-4c70-a908-6f3c8b50d13a
• NDC: 76045-203
• Product Type: Human Prescription Drug
• Proprietary Name: Glycopyrrolate
• Generic Name: Glycopyrrolate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2018-07-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209024
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: GLYCOPYRROLATE
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 76045-203-10

24 BLISTER PACK in 1 CARTON (76045-203-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-01) > 1 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2018-07-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76045-203-20 [76045020320]

Glycopyrrolate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA209024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-25

NDC 76045-203-01 [76045020301]

Glycopyrrolate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA209024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-25

NDC 76045-203-10 [76045020310]

Glycopyrrolate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA209024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-25

NDC 76045-203-02 [76045020302]

Glycopyrrolate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA209024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-25

Drug Details

Active Ingredients

Ingredient	Strength
GLYCOPYRROLATE	.2 mg/mL

OpenFDA Data

• SPL SET ID: 88d3e865-8dca-4c89-b6f7-a34c481f75b9
• Manufacturer:
  • Fresenius Kabi
• UNII:
  • V92SO9WP2I
• RxNorm Concept Unique ID - RxCUI:
  • 2101495
  • 2101490

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]

NDC Crossover Matching brand name "Glycopyrrolate" or generic name "Glycopyrrolate"

NDC	Brand Name	Generic Name
0143-1250	Glycopyrrolate	Glycopyrrolate
0143-1251	Glycopyrrolate	Glycopyrrolate
0143-9584	Glycopyrrolate	Glycopyrrolate
0143-9585	Glycopyrrolate	Glycopyrrolate
0143-9586	Glycopyrrolate	Glycopyrrolate
0143-9587	Glycopyrrolate	Glycopyrrolate
0143-9679	Glycopyrrolate	Glycopyrrolate
0143-9680	Glycopyrrolate	Glycopyrrolate
0143-9681	Glycopyrrolate	Glycopyrrolate
0143-9682	Glycopyrrolate	Glycopyrrolate
0259-0502	Glycopyrrolate	Glycopyrrolate
0404-9867	GLYCOPYRROLATE	GLYCOPYRROLATE
0404-9868	GLYCOPYRROLATE	GLYCOPYRROLATE
0404-9869	GLYCOPYRROLATE	GLYCOPYRROLATE
0404-9870	GLYCOPYRROLATE	glycopyrrolate
0517-4601	Glycopyrrolate	Glycopyrrolate
68001-353	Glycopyrrolate	Glycopyrrolate
68001-351	Glycopyrrolate	Glycopyrrolate
68001-352	Glycopyrrolate	Glycopyrrolate
68001-354	Glycopyrrolate	Glycopyrrolate
68151-0614	Glycopyrrolate	Glycopyrrolate
0517-4602	Glycopyrrolate	Glycopyrrolate
0517-4605	Glycopyrrolate	Glycopyrrolate
0517-4620	Glycopyrrolate	Glycopyrrolate
69076-475	GLYCOPYRROLATE	GLYCOPYRROLATE
69076-476	GLYCOPYRROLATE	GLYCOPYRROLATE
69067-050	Glycopyrrolate	Glycopyrrolate
69315-140	Glycopyrrolate	Glycopyrrolate
69315-139	Glycopyrrolate	Glycopyrrolate
70069-012	Glycopyrrolate	Glycopyrrolate
70121-1397	Glycopyrrolate	Glycopyrrolate
70121-1395	Glycopyrrolate	Glycopyrrolate
70121-1394	Glycopyrrolate	Glycopyrrolate
70069-014	Glycopyrrolate	Glycopyrrolate
70069-011	Glycopyrrolate	Glycopyrrolate
70069-013	Glycopyrrolate	Glycopyrrolate
70121-1396	Glycopyrrolate	Glycopyrrolate
71335-0020	Glycopyrrolate	Glycopyrrolate
71361-003	Glycopyrrolate	Glycopyrrolate
71361-002	Glycopyrrolate	Glycopyrrolate
71361-004	Glycopyrrolate	Glycopyrrolate
71872-7152	Glycopyrrolate	Glycopyrrolate
71361-001	Glycopyrrolate	Glycopyrrolate
71872-7148	Glycopyrrolate	Glycopyrrolate
71872-7012	Glycopyrrolate	Glycopyrrolate
71872-7093	Glycopyrrolate	Glycopyrrolate
71872-7094	Glycopyrrolate	Glycopyrrolate
76045-203	Glycopyrrolate	Glycopyrrolate
0615-8170	Glycopyrrolate	Glycopyrrolate
0641-6034	Glycopyrrolate	Glycopyrrolate