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United States · US · US:53746-192_9cc39ab5-450a-4e0b-948d-fdebd66c0f6f
Naproxen Sodium (NSAID)
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115374619205500 TABLET in 1 BOTTLE (53746-192-05)
- ndc1153746192088 TABLET in 1 VIAL (53746-192-08)
- ndc11537461922424 TABLET in 1 BOTTLE (53746-192-24)
Annotations
UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A079096
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9TN87S3A3C",
"rxcui": "142442",
"inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
"display_name": "NAPROXEN SODIUM",
"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": "53746-192_9cc39ab5-450a-4e0b-948d-fdebd66c0f6f",
"productndc": "53746-192",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "079096",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "220MG",
"product_no": "001",
"approval_date": "Dec 16, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "NAPROXEN SODIUM",
"proprietary_name": "Naproxen Sodium (NSAID)",
"active_ingred_unit": "mg/1",
"application_number": "ANDA079096",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen Sodium",
"start_marketing_date": "20091125",
"active_numerator_strength": "220"
}Related drugs
Other records sharing ATC code G02CC02.
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