FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
76420-954
11-digit product format
764200954
Labeler code
76420
Product ID
76420-954_30a06de6-ded3-748c-e063-6294a90afb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA077739
Marketing category
ANDA
Marketing start
2007-09-11
Substance
METOPROLOL TARTRATE
Active strength
100 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 TARTRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866511, 866514, 866924

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-954-00Metoprolol Tartrate1000 in 1 BOTTLETABLET, FILM COATED10002
76420-954-01Metoprolol Tartrate100 in 1 BOTTLETABLET, FILM COATED1002
76420-954-20Metoprolol Tartrate20 in 1 BOTTLETABLET, FILM COATED202
76420-954-30Metoprolol Tartrate30 in 1 BOTTLETABLET, FILM COATED302
76420-954-60Metoprolol Tartrate60 in 1 BOTTLETABLET, FILM COATED602
76420-954-90Metoprolol Tartrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-954METOPROLOL TARTRATE TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, 6 package rows20250322_e3de56de-b707-405e-bf97-837070e5c744.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSNe3de56de-b707-405e-bf97-837070e5c7442
866924metoprolol tartrate 25 MG Oral TabletPSNe3de56de-b707-405e-bf97-837070e5c7442
866514metoprolol tartrate 50 MG Oral TabletPSNe3de56de-b707-405e-bf97-837070e5c7442
866511metoprolol tartrate 100 MG Oral TabletSCDe3de56de-b707-405e-bf97-837070e5c7442
866924metoprolol tartrate 25 MG Oral TabletSCDe3de56de-b707-405e-bf97-837070e5c7442
866514metoprolol tartrate 50 MG Oral TabletSCDe3de56de-b707-405e-bf97-837070e5c7442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-954-00764200954001000 TABLET, FILM COATED in 1 BOTTLE (76420-954-00) 2025-03-18NoNoHistorical
76420-954-0176420095401100 TABLET, FILM COATED in 1 BOTTLE (76420-954-01) 2025-03-18NoNoHistorical
76420-954-207642009542020 TABLET, FILM COATED in 1 BOTTLE (76420-954-20) 2025-03-18NoNoHistorical
76420-954-307642009543030 TABLET, FILM COATED in 1 BOTTLE (76420-954-30) 2025-03-18NoNoHistorical
76420-954-607642009546060 TABLET, FILM COATED in 1 BOTTLE (76420-954-60) 2025-03-18NoNoHistorical
76420-954-907642009549090 TABLET, FILM COATED in 1 BOTTLE (76420-954-90) 2025-03-18NoNoHistorical