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United States · US · US:49483-618_77d2030d-4699-2117-e053-2a91aa0a6dc8
NAPROXEN
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTIME CAP LABORATORIES
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114948361801100 TABLET in 1 BOTTLE, PLASTIC (49483-618-01)
- ndc114948361850500 TABLET in 1 BOTTLE, PLASTIC (49483-618-50)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A091416
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": "49483-618_77d2030d-4699-2117-e053-2a91aa0a6dc8",
"productndc": "49483-618",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091416",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Feb 14, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "002",
"approval_date": "Feb 14, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Feb 14, 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": "ANDA091416",
"marketing_category": "ANDA",
"nonproprietary_name": "NAPROXEN",
"start_marketing_date": "20160706",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code G02CC02.
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