FDA.reportPublic FDA data

Glatopa

Product NDC
0781-3234
11-digit product format
007813234
Labeler code
0781
Product ID
0781-3234_ccec47d1-47be-4953-a7fe-ad66c9186962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glatiramer Acetate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc
Application
ANDA090218
Marketing category
ANDA
Marketing start
2015-06-18
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
Glatopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLATIRAMER ACETATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5M691HL4BO
Rxcui1111641, 1487361, 1654630, 2000007

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
0781-3234-34Glatopa1 in 1 BLISTER PACKINJECTION, SOLUTION128
0781-3234-34Glatopa30 in 1 CARTONINJECTION, SOLUTION3028
0781-3234-71Glatopa1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3234-34ML - Milliliter0781-32342d60c44e-b344-4c6c-8d24-bb6177a5ceb512015-07-20
0781-3234-71ML - Milliliter0781-3234a36b8323-9927-41c3-8418-f6ac272d454712018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLATIRAMER ACETATEACTIVE INGREDIENT5M691HL4BOGLATOPA (GLATIRAMER ACETATE) INJECTION, SOLUTION [SANDOZ INC]16
GLATIRAMERACTIVE MOIETYU782C039QPGLATOPA (GLATIRAMER ACETATE) INJECTION, SOLUTION [SANDOZ INC]16
MANNITOLINACTIVE INGREDIENT3OWL53L36AGLATOPA (GLATIRAMER ACETATE) INJECTION, SOLUTION [SANDOZ INC]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3234GLATOPA (GLATIRAMER ACETATE) INJECTION, SOLUTION [SANDOZ INC]28Current NDC, Legacy NDC, 3 package rows20250214_5f01e40a-b6f6-40fb-b37c-3d06f1428e86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111641glatiramer acetate 20 MG in 1 ML Prefilled SyringePSN0679689e-8930-4d6a-b922-5125082b2716103
1654630Glatopa 20 MG/ML in 1 ML Prefilled SyringePSN0679689e-8930-4d6a-b922-5125082b2716103
16546301 ML glatiramer acetate 20 MG/ML Prefilled Syringe [Glatopa]SBD0679689e-8930-4d6a-b922-5125082b2716103
11116411 ML glatiramer acetate 20 MG/ML Prefilled SyringeSCD0679689e-8930-4d6a-b922-5125082b2716103
16546301 ML Glatopa 20 MG/ML Prefilled SyringeSY0679689e-8930-4d6a-b922-5125082b2716103
1111641glatiramer acetate 20 MG per 1 ML Prefilled SyringeSY0679689e-8930-4d6a-b922-5125082b2716103
1111641glatiramer acetate 20 MG in 1 ML Prefilled SyringePSN5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
1487361glatiramer acetate 40 MG/ML in 1 ML Prefilled SyringePSN5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
1654630Glatopa 20 MG/ML in 1 ML Prefilled SyringePSN5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
2000007Glatopa 40 MG/ML in 1 ML Prefilled SyringePSN5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
16546301 ML glatiramer acetate 20 MG/ML Prefilled Syringe [Glatopa]SBD5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
20000071 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Glatopa]SBD5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
11116411 ML glatiramer acetate 20 MG/ML Prefilled SyringeSCD5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
14873611 ML glatiramer acetate 40 MG/ML Prefilled SyringeSCD5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
16546301 ML Glatopa 20 MG/ML Prefilled SyringeSY5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
1111641glatiramer acetate 20 MG per 1 ML Prefilled SyringeSY5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
1487361glatiramer acetate 40 MG/ML per 1 ML Prefilled SyringeSY5f01e40a-b6f6-40fb-b37c-3d06f1428e8628
2000007Glatopa 40 MG/ML per 1 ML Prefilled SyringeSY5f01e40a-b6f6-40fb-b37c-3d06f1428e8628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3234-340078132343430 BLISTER PACK in 1 CARTON (0781-3234-34) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3234-71) 30 blister pack2015-06-180000-00-00NoNoCurrent
0781-3234-71007813234711 mL in 1 SYRINGE, GLASS1 mlHistorical