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United States · US · US:76282-340_509fffe2-2bab-4ae4-8c53-520e1c5eff68
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerExelan Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117628234001100 TABLET in 1 BOTTLE (76282-340-01)
- ndc117628234005500 TABLET in 1 BOTTLE (76282-340-05)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A091305
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": "76282-340_509fffe2-2bab-4ae4-8c53-520e1c5eff68",
"productndc": "76282-340",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091305",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG",
"product_no": "001",
"approval_date": "Aug 24, 2011"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "375MG",
"product_no": "002",
"approval_date": "Aug 24, 2011"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "500MG",
"product_no": "003",
"approval_date": "Aug 24, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091305",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20160610",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code G02CC02.
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