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United States · US · US:65862-521_51d52d13-f5c1-4e80-8cb9-4aa72ad94103
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116586252101100 TABLET in 1 BOTTLE (65862-521-01)
- ndc116586252105500 TABLET in 1 BOTTLE (65862-521-05)
- ndc1165862521991000 TABLET in 1 BOTTLE (65862-521-99)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A200429
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": "65862-521_51d52d13-f5c1-4e80-8cb9-4aa72ad94103",
"productndc": "65862-521",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "200429",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Nov 8, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "002",
"approval_date": "Nov 8, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Nov 8, 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": "ANDA200429",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20111108",
"active_numerator_strength": "375"
}Related drugs
Other records sharing ATC code G02CC02.
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