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United States · US · US:47335-991_9153cc14-8516-4cdc-a47e-3b8368f573e5
Glatiramer Acetate
Orange BookUNIISPLATC L03AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeL03AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11473359910212 BLISTER PACK in 1 CARTON (47335-991-02) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
5M691HL4BO
GLATIRAMER ACETATE
RxCUI 84375
Orange Book
A206873
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": {
"7a573ffb-5dd7-43b7-8633-c69f303b1bbf": {
"match": "brand_token",
"title": "GLATIRAMER ACETATE INJECTION, SOLUTION [AJENAT PHARMACEUTICALS LLC]",
"spl_version": "2",
"published_date": "2026-04-02"
}
},
"productid": "47335-991_9153cc14-8516-4cdc-a47e-3b8368f573e5",
"productndc": "47335-991",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "206873",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Sep 25, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLATIRAMER ACETATE",
"proprietary_name": "Glatiramer Acetate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206873",
"marketing_category": "ANDA",
"nonproprietary_name": "Glatiramer Acetate",
"start_marketing_date": "20250815",
"active_numerator_strength": "40"
}Related drugs
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