Etodolac

Product NDC
63629-8805
11-digit product format
636298805
Labeler code
63629
Product ID
63629-8805_bf9bfa1f-7a0d-46b5-8504-8164d7d93a81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076004
Marketing category
ANDA
Marketing start
2003-05-01
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2M36281008ETODOLAC41340-25-4ETODOLAC

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-8805-163629880501100 TABLET, FILM COATED in 1 BOTTLE (63629-8805-1) 2003-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyBryant Ranch Prepack2025-11-14HUMAN PRESCRIPTION DRUG LABEL104