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United States · US · US:68788-7800_e522f024-b4ac-4ff4-8368-e9e6da9eb37e
Naproxen Sodium
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc116878878001100 TABLET in 1 BOTTLE (68788-7800-1)
- ndc11687887800220 TABLET in 1 BOTTLE (68788-7800-2)
- ndc11687887800330 TABLET in 1 BOTTLE (68788-7800-3)
- ndc11687887800414 TABLET in 1 BOTTLE (68788-7800-4)
- ndc11687887800660 TABLET in 1 BOTTLE (68788-7800-6)
- ndc116878878008120 TABLET in 1 BOTTLE (68788-7800-8)
- ndc11687887800990 TABLET in 1 BOTTLE (68788-7800-9)
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": "68788-7800_e522f024-b4ac-4ff4-8368-e9e6da9eb37e",
"productndc": "68788-7800",
"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": "20201013",
"active_numerator_strength": "550"
}Related drugs
Other records sharing ATC code G02CC02.
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