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United States · US · US:63629-8815_5f89076e-97c9-414a-b1d8-03abd4a46829
Glatopa
Orange BookUNIISPLATC L03AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeL03AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11636298815130 BLISTER PACK in 1 CARTON (63629-8815-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
5M691HL4BO
GLATIRAMER ACETATE
RxCUI 84375
Orange Book
A090218
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5M691HL4BO",
"rxcui": "84375",
"inchikey": null,
"display_name": "GLATIRAMER ACETATE",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"0679689e-8930-4d6a-b922-5125082b2716": {
"match": "brand_token",
"title": "GLATOPA (GLATIRAMER ACETATE) INJECTION, SOLUTION [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2025-03-31"
}
},
"productid": "63629-8815_5f89076e-97c9-414a-b1d8-03abd4a46829",
"productndc": "63629-8815",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "090218",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/ML",
"product_no": "001",
"approval_date": "Apr 16, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLATIRAMER ACETATE",
"proprietary_name": "Glatopa",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA090218",
"marketing_category": "ANDA",
"nonproprietary_name": "Glatiramer Acetate",
"start_marketing_date": "20150618",
"active_numerator_strength": "20"
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