🇺🇸
United States · US · US:63629-8816_d1f6c590-1315-4499-9fcd-75ff92dcc5c4
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
- ndc11636298816112 BLISTER PACK in 1 CARTON (63629-8816-1) / 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
A206921
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": "63629-8816_d1f6c590-1315-4499-9fcd-75ff92dcc5c4",
"productndc": "63629-8816",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "206921",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Feb 12, 2018"
}
],
"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": "ANDA206921",
"marketing_category": "ANDA",
"nonproprietary_name": "Glatiramer Acetate",
"start_marketing_date": "20180212",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L03AX13.
- IEBrabio 20 mg/ml solution for injection, pre-filled syringeViatris Limited
- NLBrabio 20 mg/ml, oplossing voor injectie in een voorgevulde spuitSynthon B.V.
- IEBrabio 40 mg/ml solution for injection in pre-filled syringeViatris Limited
- 🇨🇭Copaxone
- ISCopaxoneTEVA GmbH
- DKCopaxoneTeva GmbH
- ISCopaxoneTEVA GmbH
- DKCopaxoneTeva GmbH
Access this data programmatically
Query Glatopa and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.