NDC 70069-011

Glycopyrrolate

Glycopyrrolate

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

• Product ID: 70069-011_1cd34928-6885-4072-aedb-f6d6bdeaa1a5
• NDC: 70069-011
• Product Type: Human Prescription Drug
• Proprietary Name: Glycopyrrolate
• Generic Name: Glycopyrrolate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2017-06-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207639
• Labeler Name: Somerset Therapeutics, 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 70069-011-25

25 VIAL in 1 CARTON (70069-011-25) > 1 mL in 1 VIAL (70069-011-01)

• Marketing Start Date: 2017-06-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70069-011-01 [70069001101]

Glycopyrrolate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA207639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-06-23

NDC 70069-011-25 [70069001125]

Glycopyrrolate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA207639
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-06-23

Drug Details

Active Ingredients

Ingredient	Strength
GLYCOPYRROLATE	.2 mg/mL

OpenFDA Data

• SPL SET ID: a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6
• Manufacturer:
  • Somerset Therapeutics, LLC
• UNII:
  • V92SO9WP2I
• RxNorm Concept Unique ID - RxCUI:
  • 238212
  • 1731590
  • 1731582
• UPC Code:
  • 0370069011010
  • 0370069014011
  • 0370069013014
  • 0370069012017

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