FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
71335-9716
11-digit product format
713359716
Labeler code
71335
Product ID
71335-9716_bb25d1f5-307a-499d-8a11-9e685b1acf12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9716-1METOPROLOL TARTRATE30 in 1 BOTTLETABLET, FILM COATED30103
71335-9716-2METOPROLOL TARTRATE100 in 1 BOTTLETABLET, FILM COATED100103
71335-9716-3METOPROLOL TARTRATE60 in 1 BOTTLETABLET, FILM COATED60103
71335-9716-4METOPROLOL TARTRATE90 in 1 BOTTLETABLET, FILM COATED90103
71335-9716-5METOPROLOL TARTRATE180 in 1 BOTTLETABLET, FILM COATED180103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9716METOPROLOL TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 5 package rows20250303_22f1b399-83ad-4c2e-bb17-c11967a7471e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN22f1b399-83ad-4c2e-bb17-c11967a7471e103
866511metoprolol tartrate 100 MG Oral TabletSCD22f1b399-83ad-4c2e-bb17-c11967a7471e103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9716-17133597160130 TABLET, FILM COATED in 1 BOTTLE (71335-9716-1) 2023-05-02NoNoHistorical
71335-9716-271335971602100 TABLET, FILM COATED in 1 BOTTLE (71335-9716-2) 2023-04-25NoNoHistorical
71335-9716-37133597160360 TABLET, FILM COATED in 1 BOTTLE (71335-9716-3) 2023-06-08NoNoHistorical
71335-9716-47133597160490 TABLET, FILM COATED in 1 BOTTLE (71335-9716-4) 2023-06-19NoNoHistorical
71335-9716-571335971605180 TABLET, FILM COATED in 1 BOTTLE (71335-9716-5) 2023-06-19NoNoHistorical