FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
70518-4308
11-digit product format
705184308
Labeler code
70518
Product ID
70518-4308_402d9d6d-6bad-ad03-e063-6394a90a773c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200981
Marketing category
ANDA
Marketing start
2025-03-12
Substance
METOPROLOL TARTRATE
Active strength
25 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 TARTRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866924

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
70518-4308-0METOPROLOL TARTRATE30 in 1 BLISTER PACKTABLET304
70518-4308-1METOPROLOL TARTRATE180 in 1 BOTTLE, PLASTICTABLET1804
70518-4308-2METOPROLOL TARTRATE90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4308METOPROLOL TARTRATE TABLET [REMEDYREPACK INC.]1Current NDC, 3 package rows20250315_621249c4-531b-4138-9bde-77a06ad7816b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866924metoprolol tartrate 25 MG Oral TabletPSN621249c4-531b-4138-9bde-77a06ad7816b4
866924metoprolol tartrate 25 MG Oral TabletSCD621249c4-531b-4138-9bde-77a06ad7816b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4308-07051843080030 TABLET in 1 BLISTER PACK (70518-4308-0) 30 tablet2025-03-12NoNoHistorical
70518-4308-170518430801180 TABLET in 1 BOTTLE, PLASTIC (70518-4308-1) 180 tablet2025-08-13NoNoHistorical
70518-4308-27051843080290 TABLET in 1 BOTTLE, PLASTIC (70518-4308-2) 90 tablet2025-09-05NoNoHistorical