FDA.reportPublic FDA data

Glatopa

Product NDC
0781-3250
11-digit product format
007813250
Labeler code
0781
Product ID
0781-3250_ccec47d1-47be-4953-a7fe-ad66c9186962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glatiramer Acetate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc
Application
ANDA206921
Marketing category
ANDA
Marketing start
2018-02-12
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
Glatopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLATIRAMER ACETATE40 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
0781-3250-71Glatopa1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION128
0781-3250-89Glatopa12 in 1 CARTONINJECTION, SOLUTION1228
0781-3250-89Glatopa1 in 1 BLISTER PACKINJECTION, SOLUTION128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3250-71ML - Milliliter0781-3250eee77526-a18f-4688-8098-90d0438425ea12019-09-05
0781-3250-89ML - Milliliter0781-3250b744211a-b8b2-4edf-aa05-8d14d8d2a57b12018-03-08

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
0781-3250GLATOPA (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
1487361glatiramer acetate 40 MG/ML in 1 ML Prefilled SyringePSN028fdf0e-2340-407b-bcd8-5a99accdddbf103
2000007Glatopa 40 MG/ML in 1 ML Prefilled SyringePSN028fdf0e-2340-407b-bcd8-5a99accdddbf103
20000071 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Glatopa]SBD028fdf0e-2340-407b-bcd8-5a99accdddbf103
14873611 ML glatiramer acetate 40 MG/ML Prefilled SyringeSCD028fdf0e-2340-407b-bcd8-5a99accdddbf103
1487361glatiramer acetate 40 MG/ML per 1 ML Prefilled SyringeSY028fdf0e-2340-407b-bcd8-5a99accdddbf103
2000007Glatopa 40 MG/ML per 1 ML Prefilled SyringeSY028fdf0e-2340-407b-bcd8-5a99accdddbf103
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
0781-3250-71007813250711 mL in 1 SYRINGE, GLASS1 mlHistorical
0781-3250-890078132508912 BLISTER PACK in 1 CARTON (0781-3250-89) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3250-71) 12 blister pack2018-02-120000-00-00NoNoCurrent