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United States · US · US:52427-273_cc98185d-7e2e-eea6-8bbd-08585361b654
Naprelan
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlmatica Pharma LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11524272737575 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-273-75)
Annotations
UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
N020353
ABABAB
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": {
"b8a51c9a-488e-4377-a041-436f6a2f8893": {
"match": "brand_token",
"title": "NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]",
"spl_version": "2",
"published_date": "2026-01-09"
}
},
"productid": "52427-273_cc98185d-7e2e-eea6-8bbd-08585361b654",
"productndc": "52427-273",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "020353",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 375MG BASE",
"product_no": "001",
"approval_date": "Jan 5, 1996"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "Jan 5, 1996"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 750MG BASE",
"product_no": "003",
"approval_date": "Jan 5, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN SODIUM",
"proprietary_name": "Naprelan",
"active_ingred_unit": "mg/1",
"application_number": "NDA020353",
"marketing_category": "NDA",
"nonproprietary_name": "Naproxen Sodium",
"start_marketing_date": "20140117",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code G02CC02.
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