FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
70518-3793
11-digit product format
705183793
Labeler code
70518
Product ID
70518-3793_43d07619-60fa-01b7-e063-6294a90aeb34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200981
Marketing category
ANDA
Marketing start
2023-07-16
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3793-0METOPROLOL TARTRATE30 in 1 BLISTER PACKTABLET, FILM COATED306
70518-3793-1METOPROLOL TARTRATE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
70518-3793-2METOPROLOL TARTRATE180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3793METOPROLOL TARTRATE TABLET, FILM COATED [REMEDYREPACK INC.]4Current NDC, 3 package rows20240430_5987a15b-e86f-4fd7-a377-35a917c0e3fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN5987a15b-e86f-4fd7-a377-35a917c0e3fe6
866511metoprolol tartrate 100 MG Oral TabletSCD5987a15b-e86f-4fd7-a377-35a917c0e3fe6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3793-07051837930030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3793-0) 2023-07-16NoNoHistorical
70518-3793-17051837930190 in 1 BOTTLE, PLASTICHistorical
70518-3793-270518379302180 in 1 BOTTLE, PLASTICHistorical