FDA.reportPublic FDA data

Linezolid

Product NDC
62332-183
11-digit product format
623320183
Labeler code
62332
Product ID
62332-183_008b01d8-4425-4317-a172-4cc2a9e4e39d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA205233
Marketing category
ANDA
Marketing start
2015-12-22
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

Additional Listing Data#

Finished product
Yes
Brand name base
Linezolid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINEZOLID600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J
Rxcui311347

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-183-20Linezolid20 in 1 BOTTLETABLET, FILM COATED2017
62332-183-30Linezolid30 in 1 BOTTLETABLET, FILM COATED3017
62332-183-31Linezolid100 in 1 BOTTLETABLET, FILM COATED10017
62332-183-91Linezolid1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-183-20EA - Each62332-183fb4c4aa6-c0df-4cab-aa93-20a37eea042512016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-183LINEZOLID TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 4 package rows20200924_ca930576-62ab-4af5-ac3e-27ca376baca6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSNca930576-62ab-4af5-ac3e-27ca376baca617
311347linezolid 600 MG Oral TabletSCDca930576-62ab-4af5-ac3e-27ca376baca617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-183-206233201832020 TABLET, FILM COATED in 1 BOTTLE (62332-183-20) 2015-12-220000-00-00NoNoCurrent
62332-183-306233201833030 TABLET, FILM COATED in 1 BOTTLE (62332-183-30) 2015-12-220000-00-00NoNoCurrent
62332-183-3162332018331100 TABLET, FILM COATED in 1 BOTTLE (62332-183-31) 2015-12-220000-00-00NoNoCurrent
62332-183-91623320183911000 TABLET, FILM COATED in 1 BOTTLE (62332-183-91) 2015-12-220000-00-00NoNoCurrent