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United States · US · US:70954-925_5c522cd1-1631-4254-ae44-cef65573b29f
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117095492510100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-925-10)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A218497
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "57Y76R9ATQ",
"rxcui": "7258",
"inchikey": "CMWTZPSULFXXJA-VIFPVBQESA-N",
"display_name": "NAPROXEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c5146d73-2f34-4dfe-ac29-97071279dc4d": {
"match": "brand_token",
"title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2026-05-28"
}
},
"productid": "70954-925_5c522cd1-1631-4254-ae44-cef65573b29f",
"productndc": "70954-925",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "218497",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "001",
"approval_date": "Jun 12, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Jun 12, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218497",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20240613",
"active_numerator_strength": "375"
}Related drugs
Other records sharing ATC code G02CC02.
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