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United States · US · US:68788-8602_f6aaf43d-d2fe-45a6-b984-e3909c5e75de
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
- ndc116878886021100 TABLET in 1 BOTTLE (68788-8602-1)
- ndc11687888602220 TABLET in 1 BOTTLE (68788-8602-2)
- ndc11687888602330 TABLET in 1 BOTTLE (68788-8602-3)
- ndc11687888602440 TABLET in 1 BOTTLE (68788-8602-4)
- ndc11687888602515 TABLET in 1 BOTTLE (68788-8602-5)
- ndc11687888602660 TABLET in 1 BOTTLE (68788-8602-6)
- ndc11687888602714 TABLET in 1 BOTTLE (68788-8602-7)
- ndc116878886028120 TABLET in 1 BOTTLE (68788-8602-8)
- ndc11687888602990 TABLET in 1 BOTTLE (68788-8602-9)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A212517
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": "68788-8602_f6aaf43d-d2fe-45a6-b984-e3909c5e75de",
"productndc": "68788-8602",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212517",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Feb 21, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "002",
"approval_date": "Feb 21, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Feb 21, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212517",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20240401",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code G02CC02.
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