FDA.reportPublic FDA data

Glatiramer Acetate

Product NDC
0378-6961
11-digit product format
003786961
Labeler code
0378
Product ID
0378-6961_f5070abd-2219-47fa-8ff2-c0b147ea3eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glatiramer
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206936
Marketing category
ANDA
Marketing start
2017-10-04
Substance
GLATIRAMER ACETATE
Active strength
40 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
IngredientStrength
GLATIRAMER ACETATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5M691HL4BO
Rxcui1487361

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ee46d8-7228-4160-88ad-868cc5abf72fProduct name520260223
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487361glatiramer acetate 40 MG/ML in 1 ML Prefilled SyringePSN456a34c7-8511-4000-99a7-ad8f8de6d35e14
14873611 ML glatiramer acetate 40 MG/ML Prefilled SyringeSCD456a34c7-8511-4000-99a7-ad8f8de6d35e14
1487361glatiramer acetate 40 MG/ML per 1 ML Prefilled SyringeSY456a34c7-8511-4000-99a7-ad8f8de6d35e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6961-120037869611212 BLISTER PACK in 1 CARTON (0378-6961-12) / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32) / 1 mL in 1 SYRINGE12 blister pack2017-10-040000-00-00NoNoCurrent
0378-6961-32003786961321 in 1 BLISTER PACKHistorical