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United States · US · US:68382-273_8ceb01d9-ccec-4c22-b56b-563af9da274f
Etodolac
Orange BookUNIISPLATC M01AB08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeM01AB08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116838227301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-01)
- ndc116838227305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-05)
- ndc1168382273101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-10)
- ndc11683822731460 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-14)
- ndc116838227377100 BLISTER PACK in 1 CARTON (68382-273-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-273-30)
Annotations
UNII (FDA Substance ID)
2M36281008
ETODOLAC
RxCUI 24605
Orange Book
A091134
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2M36281008",
"rxcui": "24605",
"inchikey": "NNYBQONXHNTVIJ-UHFFFAOYSA-N",
"display_name": "ETODOLAC",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"007c55fa-ef8b-4a8e-bfe5-e47c6e5da727": {
"match": "brand_token",
"title": "ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "26",
"published_date": "2026-05-25"
}
},
"productid": "68382-273_8ceb01d9-ccec-4c22-b56b-563af9da274f",
"productndc": "68382-273",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "091134",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Jan 23, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Jan 23, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "003",
"approval_date": "Jan 23, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETODOLAC",
"proprietary_name": "Etodolac",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091134",
"marketing_category": "ANDA",
"nonproprietary_name": "Etodolac",
"start_marketing_date": "20140215",
"active_numerator_strength": "600"
}Related drugs
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