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United States · US · US:51655-363_4b3480bd-bd54-1325-e063-6394a90ad76c
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11516553632020 TABLET in 1 BOTTLE, PLASTIC (51655-363-20)
- ndc11516553632560 TABLET in 1 BOTTLE, PLASTIC (51655-363-25)
- ndc11516553632690 TABLET in 1 BOTTLE, PLASTIC (51655-363-26)
- ndc11516553635230 TABLET in 1 BOTTLE, PLASTIC (51655-363-52)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A075927
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": "51655-363_4b3480bd-bd54-1325-e063-6394a90ad76c",
"productndc": "51655-363",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075927",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Dec 18, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "002",
"approval_date": "Dec 18, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Dec 18, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075927",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20200528",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code G02CC02.
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