FDA.reportPublic FDA data

Linezolid

Product NDC
67877-419
11-digit product format
678770419
Labeler code
67877
Product ID
67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA205517
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

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-419-01Linezolid100 in 1 BOTTLETABLET, FILM COATED10019
67877-419-05Linezolid500 in 1 BOTTLETABLET, FILM COATED50019
67877-419-10Linezolid1000 in 1 BOTTLETABLET, FILM COATED100019
67877-419-20Linezolid20 in 1 BOTTLETABLET, FILM COATED2019
67877-419-33Linezolid10 in 1 BLISTER PACKTABLET, FILM COATED1019
67877-419-33Linezolid1 in 1 CARTONTABLET, FILM COATED119
67877-419-38Linezolid10 in 1 BLISTER PACKTABLET, FILM COATED1019
67877-419-38Linezolid10 in 1 CARTONTABLET, FILM COATED1019
67877-419-84Linezolid10 in 1 BLISTER PACKTABLET, FILM COATED1019
67877-419-84Linezolid3 in 1 CARTONTABLET, FILM COATED319
67877-419-85Linezolid2 in 1 CARTONTABLET, FILM COATED219
67877-419-85Linezolid10 in 1 BLISTER PACKTABLET, FILM COATED1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-419-01EA - Each67877-419db8af268-f020-4dd8-95a1-7b2e3fdd9bea12016-01-13
67877-419-20EA - Each67877-41963f6c4e7-d4cb-4cbc-a2df-a4e93b1e69d212016-01-13
67877-419-33EA - Each67877-419dce08caa-4501-41dd-bddf-4a9430309c5912019-02-13
67877-419-84EA - Each67877-4196c047792-3ea5-4706-a3af-ea47620c538212016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-419LINEZOLID TABLET, FILM COATED [ASCEND LABORATORIES, LLC]17Current NDC, Legacy NDC, 12 package rows20231210_7402aa01-50de-46c8-a341-d30da5b32b1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSN7402aa01-50de-46c8-a341-d30da5b32b1c19
311347linezolid 600 MG Oral TabletSCD7402aa01-50de-46c8-a341-d30da5b32b1c19
311347linezolid 600 MG Oral TabletPSN3e0d868d-f419-47e8-a3bc-41ececac468b4
311347linezolid 600 MG Oral TabletSCD3e0d868d-f419-47e8-a3bc-41ececac468b4
311347linezolid 600 MG Oral TabletPSNab1b4ab5-7338-4b01-963b-43eeb4c9cf1c3
311347linezolid 600 MG Oral TabletSCDab1b4ab5-7338-4b01-963b-43eeb4c9cf1c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-419-0167877041901100 TABLET, FILM COATED in 1 BOTTLE (67877-419-01) 2015-12-210000-00-00NoNoCurrent
67877-419-0567877041905500 TABLET, FILM COATED in 1 BOTTLE (67877-419-05) 2015-12-210000-00-00NoNoCurrent
67877-419-10678770419101000 TABLET, FILM COATED in 1 BOTTLE (67877-419-10) 2015-12-210000-00-00NoNoCurrent
67877-419-206787704192020 TABLET, FILM COATED in 1 BOTTLE (67877-419-20) 2015-12-210000-00-00NoNoCurrent
67877-419-33678770419331 BLISTER PACK in 1 CARTON (67877-419-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-12-210000-00-00NoNoCurrent
67877-419-386787704193810 BLISTER PACK in 1 CARTON (67877-419-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-12-210000-00-00NoNoCurrent
67877-419-84678770419843 BLISTER PACK in 1 CARTON (67877-419-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2015-12-210000-00-00NoNoCurrent
67877-419-85678770419852 BLISTER PACK in 1 CARTON (67877-419-85) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2015-12-210000-00-00NoNoCurrent