FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
50090-5060
11-digit product format
500905060
Labeler code
50090
Product ID
50090-5060_57110203-5ffb-4e13-a8f2-004a3336cf92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
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 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
50090-5060-02023-02-06C16284748780-1f386c649-df9b-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
50090-5060-02023-01-30C16284748780-1f386c649-df9b-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
50090-5060-0Metoprolol Tartrate90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5060-0EA - Each50090-5060274c0b76-dd98-473f-bbf1-bd2d2f6034ba12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5060METOPROLOL TARTRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20230921_5b423eba-0a35-41b0-9338-fa4c6f5c6c7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866514metoprolol tartrate 50 MG Oral TabletPSN5b423eba-0a35-41b0-9338-fa4c6f5c6c7f7
866514metoprolol tartrate 50 MG Oral TabletSCD5b423eba-0a35-41b0-9338-fa4c6f5c6c7f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5060-05009050600090 TABLET, FILM COATED in 1 BOTTLE (50090-5060-0) 2020-05-260000-00-00NoNoCurrent