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United States · US · US:68788-8797_9ad5813d-635f-4829-9e46-7cf61c64238f
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 9
- ndc116878887971100 TABLET in 1 BOTTLE (68788-8797-1)
- ndc11687888797220 TABLET in 1 BOTTLE (68788-8797-2)
- ndc11687888797330 TABLET in 1 BOTTLE (68788-8797-3)
- ndc11687888797440 TABLET in 1 BOTTLE (68788-8797-4)
- ndc11687888797515 TABLET in 1 BOTTLE (68788-8797-5)
- ndc11687888797660 TABLET in 1 BOTTLE (68788-8797-6)
- ndc11687888797714 TABLET in 1 BOTTLE (68788-8797-7)
- ndc116878887978120 TABLET in 1 BOTTLE (68788-8797-8)
- ndc11687888797990 TABLET in 1 BOTTLE (68788-8797-9)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A078250
ABABAB
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": "68788-8797_9ad5813d-635f-4829-9e46-7cf61c64238f",
"productndc": "68788-8797",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078250",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Mar 28, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "002",
"approval_date": "Mar 28, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Mar 28, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078250",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20250101",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code G02CC02.
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