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United States · US · US:70518-4439_4f0c17b4-ee4f-026c-e063-6394a90ac5c4
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11705184439012 TABLET in 1 BOTTLE, PLASTIC (70518-4439-0)
- ndc11705184439120 TABLET in 1 BOTTLE, PLASTIC (70518-4439-1)
- ndc11705184439230 TABLET in 1 BOTTLE, PLASTIC (70518-4439-2)
- ndc11705184439390 TABLET in 1 BOTTLE, PLASTIC (70518-4439-3)
- ndc11705184439430 TABLET in 1 BOTTLE, PLASTIC (70518-4439-4)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A074140
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": "70518-4439_4f0c17b4-ee4f-026c-e063-6394a90ac5c4",
"productndc": "70518-4439",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "074140",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Dec 21, 1993"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "002",
"approval_date": "Dec 21, 1993"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Dec 21, 1993"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA074140",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20250813",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code G02CC02.
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