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United States · US · US:43063-600_39f936c5-d0d1-6804-e063-6394a90add94
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1143063600066 TABLET in 1 BOTTLE, PLASTIC (43063-600-06)
- ndc11430636001515 TABLET in 1 BOTTLE, PLASTIC (43063-600-15)
- ndc11430636002020 TABLET in 1 BOTTLE, PLASTIC (43063-600-20)
- ndc11430636003030 TABLET in 1 BOTTLE, PLASTIC (43063-600-30)
- ndc11430636006060 TABLET in 1 BOTTLE, PLASTIC (43063-600-60)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A075927
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": "43063-600_39f936c5-d0d1-6804-e063-6394a90add94",
"productndc": "43063-600",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075927",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Dec 18, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "002",
"approval_date": "Dec 18, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Dec 18, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075927",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20100218",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code G02CC02.
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