FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
70518-3293
11-digit product format
705183293
Labeler code
70518
Product ID
70518-3293_4ef1da6f-4e40-9164-e063-6294a90aafe4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077739
Marketing category
ANDA
Marketing start
2021-12-13
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3293-0Metoprolol Tartrate60 in 1 BLISTER PACKTABLET, FILM COATED6012
70518-3293-1Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18012
70518-3293-2Metoprolol Tartrate30 in 1 BLISTER PACKTABLET, FILM COATED3012
70518-3293-3Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3293METOPROLOL TARTRATE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20241003_3a236293-35c1-4083-9805-ab40df535083.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866514metoprolol tartrate 50 MG Oral TabletPSN3a236293-35c1-4083-9805-ab40df53508312
866514metoprolol tartrate 50 MG Oral TabletSCD3a236293-35c1-4083-9805-ab40df53508312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3293-07051832930060 TABLET, FILM COATED in 1 BLISTER PACK (70518-3293-0) 2021-12-130000-00-00NoNoCurrent
70518-3293-170518329301180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3293-1) 2021-12-300000-00-00NoNoCurrent
70518-3293-27051832930230 TABLET, FILM COATED in 1 BLISTER PACK (70518-3293-2) 2022-02-030000-00-00NoNoCurrent
70518-3293-37051832930390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3293-3) 2022-02-170000-00-00NoNoCurrent