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United States · US · US:25000-138_e5013319-e2f4-4cd0-9523-1ffd352fe2d9
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11250001380330 TABLET in 1 BOTTLE (25000-138-03)
- ndc1125000138141000 TABLET in 1 BOTTLE (25000-138-14)
- ndc1125000138214 BAG in 1 BOX (25000-138-21) / 7500 TABLET in 1 BAG
- ndc1125000138316 BAG in 1 BOX (25000-138-31) / 7500 TABLET in 1 BAG
- ndc1125000138981 BAG in 1 BOX (25000-138-98) / 37950 TABLET in 1 BAG
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": "25000-138_e5013319-e2f4-4cd0-9523-1ffd352fe2d9",
"productndc": "25000-138",
"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": "20110228",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code G02CC02.
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