FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
71335-1142
11-digit product format
713351142
Labeler code
71335
Product ID
71335-1142_b00996cc-27c9-44e1-be76-1d411b6024cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200981
Marketing category
ANDA
Marketing start
2018-12-01
Substance
METOPROLOL TARTRATE
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866924

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1142-12025-02-21C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-22025-02-21C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-32025-02-21C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-42025-02-21C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-52025-02-21C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-62025-02-21C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-72025-02-21C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-82025-02-21C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-12024-01-30C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-22024-01-30C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-32024-01-30C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-42024-01-30C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-52024-01-30C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-62024-01-30C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-72024-01-30C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
71335-1142-82024-01-30C16284748780-11030e365-267e-111a-e063-dadaa90a10e2METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1142-1Metoprolol Tartrate30 in 1 BOTTLETABLET, FILM COATED305
71335-1142-2Metoprolol Tartrate60 in 1 BOTTLETABLET, FILM COATED605
71335-1142-3Metoprolol Tartrate90 in 1 BOTTLETABLET, FILM COATED905
71335-1142-4Metoprolol Tartrate180 in 1 BOTTLETABLET, FILM COATED1805
71335-1142-5Metoprolol Tartrate100 in 1 BOTTLETABLET, FILM COATED1005
71335-1142-6Metoprolol Tartrate120 in 1 BOTTLETABLET, FILM COATED1205
71335-1142-7Metoprolol Tartrate20 in 1 BOTTLETABLET, FILM COATED205
71335-1142-8Metoprolol Tartrate10 in 1 BOTTLETABLET, FILM COATED105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1142METOPROLOL TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20250224_bac92e34-efe3-4c20-a7bd-6a5382459f9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866924metoprolol tartrate 25 MG Oral TabletPSNbac92e34-efe3-4c20-a7bd-6a5382459f9c5
866924metoprolol tartrate 25 MG Oral TabletSCDbac92e34-efe3-4c20-a7bd-6a5382459f9c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1142-17133511420130 TABLET, FILM COATED in 1 BOTTLE (71335-1142-1) 2019-09-050000-00-00NoNoCurrent
71335-1142-27133511420260 TABLET, FILM COATED in 1 BOTTLE (71335-1142-2) 2019-07-020000-00-00NoNoCurrent
71335-1142-37133511420390 TABLET, FILM COATED in 1 BOTTLE (71335-1142-3) 2019-03-110000-00-00NoNoCurrent
71335-1142-471335114204180 TABLET, FILM COATED in 1 BOTTLE (71335-1142-4) 2019-05-280000-00-00NoNoCurrent
71335-1142-571335114205100 TABLET, FILM COATED in 1 BOTTLE (71335-1142-5) 2019-08-060000-00-00NoNoCurrent
71335-1142-671335114206120 TABLET, FILM COATED in 1 BOTTLE (71335-1142-6) 2019-06-250000-00-00NoNoCurrent
71335-1142-77133511420720 TABLET, FILM COATED in 1 BOTTLE (71335-1142-7) 2019-03-190000-00-00NoNoCurrent
71335-1142-87133511420810 TABLET, FILM COATED in 1 BOTTLE (71335-1142-8) 2025-01-290000-00-00NoNoCurrent