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United States · US · US:53185-604_b5125434-5aab-4cbd-afba-c6ca1381b2a9
Naproxen Sodium
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAthlete's Needs Inc
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115318560412100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-12)
- ndc11531856041550 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-15)
Annotations
UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A204872
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": "53185-604_b5125434-5aab-4cbd-afba-c6ca1381b2a9",
"productndc": "53185-604",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204872",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "220MG",
"product_no": "001",
"approval_date": "Jan 23, 2017"
}
],
"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": "ANDA204872",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen Sodium",
"start_marketing_date": "20220311",
"active_numerator_strength": "220"
}Related drugs
Other records sharing ATC code G02CC02.
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