FDA.reportPublic FDA data

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
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
0378-6961-12Glatiramer Acetate12 in 1 CARTONINJECTION, SOLUTION1214
0378-6961-32Glatiramer Acetate1 in 1 BLISTER PACKINJECTION, SOLUTION114
0378-6961-32Glatiramer Acetate1 mL in 1 SYRINGEINJECTION, SOLUTION114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6961GLATIRAMER ACETATE (GLATIRAMER) INJECTION, SOLUTION [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 3 package rows20250515_456a34c7-8511-4000-99a7-ad8f8de6d35e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6961-12ML - Milliliter0378-6961f5c8bb2f-60fd-4b4e-a42d-09ecb96fd24e12017-11-06
0378-6961-32ML - Milliliter0378-6961cfd8ac14-f76a-46a9-b1fd-e114a0782fa712017-11-06

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 2 · 23 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
rxcui: 1487361
unii: 5M691HL4BO
GLATIRAMER ACETATEGLATIRAMER ACETATEZydus Pharmaceuticals USA Inc.0aa4ff2a-ce8e-46cd-830f-a264cc582be22026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
unii: 5M691HL4BO
GlatopaGLATIRAMER ACETATESandoz Inc5f01e40a-b6f6-40fb-b37c-3d06f1428e862026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
unii: 5M691HL4BO
CopaxoneGLATIRAMER ACETATETeva Neuroscience, Inc.aa88f583-4f5f-433b-80b4-1f4c9fb283572026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
unii: 5M691HL4BO
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Glatiramer AcetateGLATIRAMER ACETATE INJECTIONUPSHER-SMITH LABORATORIES, LLC707a64ef-964e-44a3-8a0f-fcc2eb5b1af22026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
unii: 5M691HL4BO
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
GLATIRAMER ACETATEGLATIRAMER ACETATEItalfarmaco SpA1b3a60de-2191-4b15-be69-01329da877112025-10-31Exact identifier
rxcui: 1487361
unii: 5M691HL4BO
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
GlatopaGLATIRAMER ACETATEBryant Ranch Prepack0679689e-8930-4d6a-b922-5125082b27162025-03-27Warnings, Adverse reactionsExact identifier
unii: 5M691HL4BO
GlatopaGLATIRAMER ACETATEBryant Ranch Prepack028fdf0e-2340-407b-bcd8-5a99accdddbf2025-03-27Warnings, Adverse reactionsExact identifier
rxcui: 1487361
unii: 5M691HL4BO
Glatiramer AcetateGLATIRAMER ACETATESun Pharmaceutical Industries, Inc.f90cc5f5-56a1-48dc-a4fc-0ae89ef61deb2025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5M691HL4BO
Glatiramer AcetateGLATIRAMER ACETATESun Pharmaceutical Industries, Inc.dfacc3e2-5c91-41de-a377-873276a5cf672025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
unii: 5M691HL4BO
Glatiramer AcetateGLATIRAMER ACETATEMylan Pharmaceuticals Inc.f38b5606-d2d7-44ec-912f-46882aa2fa7b2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5M691HL4BO
Glatiramer AcetateGLATIRAMERMylan Pharmaceuticals Inc.456a34c7-8511-4000-99a7-ad8f8de6d35e2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206936
ndc (package): 0378-6961-12
ndc (package): 0378-6961-32
ndc (product): 0378-6961
ndc11 (package): 00378696132
rxcui: 1487361
spl id: f5070abd-2219-47fa-8ff2-c0b147ea3eb7
spl set id: 456a34c7-8511-4000-99a7-ad8f8de6d35e
unii: 5M691HL4BO

Reported adverse events (FAERS/openFDA)#

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