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United States · US · US:69097-853_598c64ad-f0c4-495e-b2c2-cde215d2572d
naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116909785307100 TABLET in 1 BOTTLE (69097-853-07)
- ndc116909785312500 TABLET in 1 BOTTLE (69097-853-12)
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": "69097-853_598c64ad-f0c4-495e-b2c2-cde215d2572d",
"productndc": "69097-853",
"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": "20160705",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code G02CC02.
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