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United States · US · US:76420-627_07f76fa9-dba3-997b-e063-6294a90a6dd5
Naproxen Sodium
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117642062701100 TABLET in 1 BOTTLE (76420-627-01)
- ndc11764206273030 TABLET in 1 BOTTLE (76420-627-30)
- ndc11764206276060 TABLET in 1 BOTTLE (76420-627-60)
- ndc11764206279090 TABLET in 1 BOTTLE (76420-627-90)
Annotations
UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A212199
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": "76420-627_07f76fa9-dba3-997b-e063-6294a90a6dd5",
"productndc": "76420-627",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212199",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Oct 30, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "Oct 30, 2019"
}
],
"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": "ANDA212199",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen Sodium",
"start_marketing_date": "20191030",
"active_numerator_strength": "550"
}Related drugs
Other records sharing ATC code G02CC02.
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