FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
72888-101
11-digit product format
728880101
Labeler code
72888
Product ID
72888-101_48450d44-3cc6-45be-e063-6394a90aac70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA200981
Marketing category
ANDA
Marketing start
2018-12-01
Substance
METOPROLOL TARTRATE
Active strength
37.5 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 TARTRATE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866511, 866514, 866924, 1606347, 1606349

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
72888-101-01METOPROLOL TARTRATE100 in 1 PACKAGETABLET, FILM COATED1006
72888-101-05METOPROLOL TARTRATE500 in 1 PACKAGETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-101-01EA - Each72888-1011ddc9585-655a-4f9c-86e3-30cb3269259412021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-101METOPROLOL TARTRATE TABLET, FILM COATED [ADVAGEN PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20241224_a401fe31-d51a-49d9-a062-c9d22088db56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSNa401fe31-d51a-49d9-a062-c9d22088db566
866924metoprolol tartrate 25 MG Oral TabletPSNa401fe31-d51a-49d9-a062-c9d22088db566
1606347metoprolol tartrate 37.5 MG Oral TabletPSNa401fe31-d51a-49d9-a062-c9d22088db566
866514metoprolol tartrate 50 MG Oral TabletPSNa401fe31-d51a-49d9-a062-c9d22088db566
1606349metoprolol tartrate 75 MG Oral TabletPSNa401fe31-d51a-49d9-a062-c9d22088db566
866511metoprolol tartrate 100 MG Oral TabletSCDa401fe31-d51a-49d9-a062-c9d22088db566
866924metoprolol tartrate 25 MG Oral TabletSCDa401fe31-d51a-49d9-a062-c9d22088db566
1606347metoprolol tartrate 37.5 MG Oral TabletSCDa401fe31-d51a-49d9-a062-c9d22088db566
866514metoprolol tartrate 50 MG Oral TabletSCDa401fe31-d51a-49d9-a062-c9d22088db566
1606349metoprolol tartrate 75 MG Oral TabletSCDa401fe31-d51a-49d9-a062-c9d22088db566

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-101-0172888010101100 TABLET, FILM COATED in 1 PACKAGE (72888-101-01) 2024-10-180000-00-00NoNoCurrent
72888-101-0572888010105500 TABLET, FILM COATED in 1 PACKAGE (72888-101-05) 2024-10-180000-00-00NoNoCurrent