FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
68071-4880
11-digit product format
680714880
Labeler code
68071
Product ID
68071-4880_1ae1cc9d-0254-361f-e063-6394a90a966b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA200981
Marketing category
ANDA
Marketing start
2018-12-01
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

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
68071-4880-92021-02-17C16284748780-1ba0f9c33-4f58-a910-e053-dadaa90a0b85METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only
68071-4880-92021-01-29C16284748780-1ba0f9c33-4f58-a910-e053-dadaa90a0b85METOPROLOL TARTRATE TABLETS, USP TruPharma LLC R x only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4880-1Metoprolol Tartrate120 in 1 BOTTLETABLET, FILM COATED1204
68071-4880-9Metoprolol Tartrate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4880METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240616_87ef9aa6-2faa-0f77-e053-2a95a90a3a26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN87ef9aa6-2faa-0f77-e053-2a95a90a3a264
866511metoprolol tartrate 100 MG Oral TabletSCD87ef9aa6-2faa-0f77-e053-2a95a90a3a264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4880-168071488001120 TABLET, FILM COATED in 1 BOTTLE (68071-4880-1) 2019-05-020000-00-00NoNoCurrent
68071-4880-96807148800990 TABLET, FILM COATED in 1 BOTTLE (68071-4880-9) 2019-05-020000-00-00NoNoCurrent