FDA.reportPublic FDA data

NDC 0378-6960-32 - 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
0378-6960
Requested NDC
0378-6960-32
Package NDCs from labels
0378-6960-32, 0378-6960-93
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
LabelManufacturerEffective dateType
Glatiramer Acetate - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2025-02-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-6960-32Glatiramer Acetate1 mL in 1 SYRINGEINJECTION, SOLUTION114
0378-6960-32Glatiramer Acetate1 in 1 BLISTER PACKINJECTION, SOLUTION114
0378-6960-93Glatiramer Acetate30 in 1 CARTONINJECTION, SOLUTION3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6960GLATIRAMER ACETATE INJECTION, SOLUTION [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 3 package rows20250515_f38b5606-d2d7-44ec-912f-46882aa2fa7b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6960-32ML - Milliliter0378-69602bcfe541-001d-4661-8d60-b9ff7aadb98312017-11-06
0378-6960-93ML - Milliliter0378-6960759793dc-7acb-4399-8a5f-674a6e92233412017-11-06

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 1 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glatiramer AcetateGLATIRAMER ACETATEAJENAT PHARMACEUTICALS LLC1ec10223-880d-402f-a759-9cd179bf09de2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5M691HL4BO
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GLATIRAMER ACETATEGLATIRAMER ACETATEZydus Pharmaceuticals USA Inc.0aa4ff2a-ce8e-46cd-830f-a264cc582be22026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
unii: 5M691HL4BO
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlatopaGLATIRAMER ACETATESandoz Inc5f01e40a-b6f6-40fb-b37c-3d06f1428e862026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
unii: 5M691HL4BO
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
CopaxoneGLATIRAMER ACETATETeva Neuroscience, Inc.aa88f583-4f5f-433b-80b4-1f4c9fb283572026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
unii: 5M691HL4BO
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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