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United States · US · US:76420-788_14060e9c-4605-5493-e063-6294a90ab6d3
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc1176420788011 TABLET in 1 BOTTLE (76420-788-01)
- ndc1176420788022 TABLET in 1 BOTTLE (76420-788-02)
- ndc117642078805500 TABLET in 1 BOTTLE (76420-788-05)
- ndc1176420788077 TABLET in 1 BOTTLE (76420-788-07)
- ndc117642078810100 TABLET in 1 BOTTLE (76420-788-10)
- ndc11764207881414 TABLET in 1 BOTTLE (76420-788-14)
- ndc11764207882020 TABLET in 1 BOTTLE (76420-788-20)
- ndc11764207883030 TABLET in 1 BOTTLE (76420-788-30)
- ndc11764207886060 TABLET in 1 BOTTLE (76420-788-60)
- ndc11764207889090 TABLET in 1 BOTTLE (76420-788-90)
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": "76420-788_14060e9c-4605-5493-e063-6294a90ab6d3",
"productndc": "76420-788",
"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": "20200301",
"active_numerator_strength": "375"
}Related drugs
Other records sharing ATC code G02CC02.
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