Glatiramer Acetate

Product NDC: 0378-6960
11-digit product format: 003786960
Labeler code: 0378
Product ID: 0378-6960_b7562df3-2e18-4454-83e9-e0ebaccf25a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glatiramer acetate
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA091646
Marketing category: ANDA
Marketing start: 2017-10-04
Substance: GLATIRAMER ACETATE
Active strength: 20 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Glatiramer Acetate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLATIRAMER ACETATE	20 mg/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	5M691HL4BO
Rxcui	1111641

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a4ee46d8-7228-4160-88ad-868cc5abf72f	Product name	5	20260223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-6960-32	Glatiramer Acetate	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1		14
0378-6960-32	Glatiramer Acetate	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1		14
0378-6960-93	Glatiramer Acetate	30 in 1 CARTON	INJECTION, SOLUTION	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6960-32	ML - Milliliter	0378-6960	2bcfe541-001d-4661-8d60-b9ff7aadb983	1	2017-11-06
0378-6960-93	ML - Milliliter	0378-6960	759793dc-7acb-4399-8a5f-674a6e922334	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-6960	GLATIRAMER ACETATE INJECTION, SOLUTION [MYLAN PHARMACEUTICALS INC.]	14	Current NDC, Legacy NDC, 3 package rows	20250515_f38b5606-d2d7-44ec-912f-46882aa2fa7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111641	glatiramer acetate 20 MG in 1 ML Prefilled Syringe	PSN	f38b5606-d2d7-44ec-912f-46882aa2fa7b	14
1111641	1 ML glatiramer acetate 20 MG/ML Prefilled Syringe	SCD	f38b5606-d2d7-44ec-912f-46882aa2fa7b	14
1111641	glatiramer acetate 20 MG per 1 ML Prefilled Syringe	SY	f38b5606-d2d7-44ec-912f-46882aa2fa7b	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-6960-32	00378696032	1 mL in 1 SYRINGE	1 ml					Historical
0378-6960-93	00378696093	30 BLISTER PACK in 1 CARTON (0378-6960-93) / 1 SYRINGE in 1 BLISTER PACK (0378-6960-32) / 1 mL in 1 SYRINGE	30 blister pack	2017-10-04	0000-00-00	No	No	Current