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United States · US · US:0378-6961_f5070abd-2219-47fa-8ff2-c0b147ea3eb7
Glatiramer Acetate
Orange BookUNIISPLATC L03AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL03AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037869611212 BLISTER PACK in 1 CARTON (0378-6961-12) / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32) / 1 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
5M691HL4BO
GLATIRAMER ACETATE
RxCUI 84375
Orange Book
A206936
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": "0378-6961_f5070abd-2219-47fa-8ff2-c0b147ea3eb7",
"productndc": "0378-6961",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "206936",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Oct 3, 2017"
}
],
"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": "ANDA206936",
"marketing_category": "ANDA",
"nonproprietary_name": "Glatiramer",
"start_marketing_date": "20171004",
"active_numerator_strength": "40"
}Related drugs
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