FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
42708-041
11-digit product format
427080041
Labeler code
42708
Product ID
42708-041_45b3f0b5-aff2-8f42-e063-6394a90a0203
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma Inc
Application
ANDA077739
Marketing category
ANDA
Marketing start
2007-09-11
Substance
METOPROLOL TARTRATE
Active strength
50 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 TARTRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866514

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
42708-041-602021-03-12C16284748780-1ba0f9c33-5b68-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METOPROLOL TARTRATE TABLETS safely and effectively. See full prescribing information for METOPROLOL TARTRATE TABLETS. METOPROLOL TARTRATE tablets, for oral use Initial U.S. Approval: 1992
42708-041-602021-01-29C16284748780-1ba0f9c33-5b68-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METOPROLOL TARTRATE TABLETS safely and effectively. See full prescribing information for METOPROLOL TARTRATE TABLETS. METOPROLOL TARTRATE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-041-60Metoprolol Tartrate60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-041METOPROLOL TARTRATE TABLET, FILM COATED [QPHARMA INC]5Current NDC, Legacy NDC, 1 package rows20240515_2ad0606c-7a90-44bd-a75d-d256de30fbcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866514metoprolol tartrate 50 MG Oral TabletPSN2ad0606c-7a90-44bd-a75d-d256de30fbcf6
866514metoprolol tartrate 50 MG Oral TabletSCD2ad0606c-7a90-44bd-a75d-d256de30fbcf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-041-604270800416060 TABLET, FILM COATED in 1 BOTTLE (42708-041-60) 2018-03-300000-00-00YesNoCurrent