FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
70518-3291
11-digit product format
705183291
Labeler code
70518
Product ID
70518-3291_4ee39713-28af-8bbb-e063-6294a90a9f39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077739
Marketing category
ANDA
Marketing start
2021-12-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate
Listing expiration
2027-12-31

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
70518-3291-02023-03-23C16284748780-1f386c649-da7a-0266-e053-dadaa90a7c1aThese 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
70518-3291-02023-01-30C16284748780-1f386c649-da7a-0266-e053-dadaa90a7c1aThese 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
70518-3291-0Metoprolol Tartrate60 in 1 BLISTER PACKTABLET, FILM COATED6011
70518-3291-1Metoprolol Tartrate30 in 1 BLISTER PACKTABLET, FILM COATED3011
70518-3291-2Metoprolol Tartrate30 in 1 BLISTER PACKTABLET, FILM COATED3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3291METOPROLOL TARTRATE TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 3 package rows20250330_c9ccdbc0-0e4e-40c4-aacf-de60deda9fd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866924metoprolol tartrate 25 MG Oral TabletPSNc9ccdbc0-0e4e-40c4-aacf-de60deda9fd511
866924metoprolol tartrate 25 MG Oral TabletSCDc9ccdbc0-0e4e-40c4-aacf-de60deda9fd511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3291-07051832910060 TABLET, FILM COATED in 1 BLISTER PACK (70518-3291-0) 2021-12-130000-00-00NoNoCurrent
70518-3291-17051832910130 TABLET, FILM COATED in 1 BLISTER PACK (70518-3291-1) 2023-07-20NoNoHistorical
70518-3291-27051832910230 in 1 BLISTER PACKHistorical