NDC 0378-6961-32 - Glatiramer Acetate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0378-6961
Requested NDC: 0378-6961-32
Package NDCs from labels: 0378-6961-32, 0378-6961-12
Manufacturer: Mylan Pharmaceuticals Inc.
Effective date: 2025-02-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Glatiramer Acetate - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2025-02-07	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-6961-12	Glatiramer Acetate	12 in 1 CARTON	INJECTION, SOLUTION	12	14
0378-6961-32	Glatiramer Acetate	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	14
0378-6961-32	Glatiramer Acetate	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-6961	GLATIRAMER ACETATE (GLATIRAMER) INJECTION, SOLUTION [MYLAN PHARMACEUTICALS INC.]	14	Current NDC, Legacy NDC, 3 package rows	20250515_456a34c7-8511-4000-99a7-ad8f8de6d35e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6961-12	ML - Milliliter	0378-6961	f5c8bb2f-60fd-4b4e-a42d-09ecb96fd24e	1	2017-11-06
0378-6961-32	ML - Milliliter	0378-6961	cfd8ac14-f76a-46a9-b1fd-e114a0782fa7	1	2017-11-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MANNITOL	MANNITOL	HF Acquisition Co LLC, DBA HealthFirst	999ce711-2d5b-0d7d-e053-2995a90a2689	2024-01-27	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Mannitol	MANNITOL	B. Braun Medical Inc.	d12cc802-b538-4065-a264-f474ff3b3043	2023-08-15	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.