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United States · US · US:42192-619_47a98b71-a338-b13d-e063-6394a90a96f6
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcella Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114219261916473 mL in 1 BOTTLE (42192-619-16)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
N018965
AB
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": "42192-619_47a98b71-a338-b13d-e063-6394a90a96f6",
"productndc": "42192-619",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "018965",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG/ML",
"product_no": "001",
"approval_date": "Mar 23, 1987"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA018965",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20201112",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code G02CC02.
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