Linezolid

Product NDC
63629-8576
11-digit product format
636298576
Labeler code
63629
Product ID
63629-8576_0bf00238-038a-43dd-91bd-148aaa13f219
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204239
Marketing category
ANDA
Marketing start
2015-12-21
Substance
LINEZOLID
Active strength
600 mg/1
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
ISQ9I6J12JLINEZOLID165800-03-3LINEZOLID

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-8576-16362985760120 TABLET, FILM COATED in 1 BOTTLE (63629-8576-1) 2021-12-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LinezolidBryant Ranch Prepack2025-08-26HUMAN PRESCRIPTION DRUG LABEL103