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United States · US · US:83324-109_3806291c-fce8-bcac-e063-6294a90ae162
Naproxen Sodium
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCHAIN DRUG MARKETING ASSOCIATION, INC.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1183324109011 BOTTLE, PLASTIC in 1 PACKAGE (83324-109-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
- ndc1183324109501 BOTTLE, PLASTIC in 1 CARTON (83324-109-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
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": "83324-109_3806291c-fce8-bcac-e063-6294a90ae162",
"productndc": "83324-109",
"dosage_form": "TABLET, COATED",
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA079096",
"marketing_category": "ANDA",
"nonproprietary_name": "NAPROXEN SODIUM",
"start_marketing_date": "20250520",
"active_numerator_strength": "220"
}Related drugs
Other records sharing ATC code G02CC02.
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