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United States · US · US:69238-1730_3b37ffd3-034c-424c-bca0-72f15d719633
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116923817302473 mL in 1 BOTTLE (69238-1730-2)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A212705
AB
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": "69238-1730_3b37ffd3-034c-424c-bca0-72f15d719633",
"productndc": "69238-1730",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "212705",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG/ML",
"product_no": "001",
"approval_date": "Jul 31, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212705",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20200803",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code G02CC02.
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