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United States · US · US:65862-515_a4659cf5-a74b-42b3-968b-a8e4f14f94aa
Naproxen Sodium
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116586251501100 TABLET, FILM COATED in 1 BOTTLE (65862-515-01)
- ndc116586251505500 TABLET, FILM COATED in 1 BOTTLE (65862-515-05)
- ndc1165862515991000 TABLET, FILM COATED in 1 BOTTLE (65862-515-99)
Annotations
UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A200629
ABAB
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": "65862-515_a4659cf5-a74b-42b3-968b-a8e4f14f94aa",
"productndc": "65862-515",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "200629",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Oct 31, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "Oct 31, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN SODIUM",
"proprietary_name": "Naproxen Sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200629",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen Sodium",
"start_marketing_date": "20111031",
"active_numerator_strength": "275"
}Related drugs
Other records sharing ATC code G02CC02.
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