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United States · US · US:71610-816_1547fa22-2822-34ef-e063-6394a90aee62
Etodolac
Orange BookUNIISPLATC M01AB08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeM01AB08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11716108165360 TABLET, FILM COATED in 1 BOTTLE (71610-816-53)
- ndc11716108166090 TABLET, FILM COATED in 1 BOTTLE (71610-816-60)
- ndc117161081680180 TABLET, FILM COATED in 1 BOTTLE (71610-816-80)
Annotations
UNII (FDA Substance ID)
2M36281008
ETODOLAC
RxCUI 24605
Orange Book
A075074
ABAB
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": "71610-816_1547fa22-2822-34ef-e063-6394a90aee62",
"productndc": "71610-816",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "075074",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Mar 11, 1998"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Apr 25, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETODOLAC",
"proprietary_name": "Etodolac",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075074",
"marketing_category": "ANDA",
"nonproprietary_name": "Etodolac",
"start_marketing_date": "19980311",
"active_numerator_strength": "400"
}Related drugs
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