FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
72888-211
11-digit product format
728880211
Labeler code
72888
Product ID
72888-211_3e9a73a5-7f4a-1caa-e063-6394a90a89bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA200981
Marketing category
ANDA
Marketing start
2024-07-26
Substance
METOPROLOL TARTRATE
Active strength
75 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 TARTRATE75 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
72888-211-01METOPROLOL TARTRATE100 in 1 BOTTLETABLET1002
72888-211-05METOPROLOL TARTRATE500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-211METOPROLOL TARTRATE TABLET [ADVAGEN PHARMA LTD]1Current NDC, 2 package rows20240907_3ecff825-34ea-4535-b935-627bf2c13d93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN3ecff825-34ea-4535-b935-627bf2c13d932
866924metoprolol tartrate 25 MG Oral TabletPSN3ecff825-34ea-4535-b935-627bf2c13d932
1606347metoprolol tartrate 37.5 MG Oral TabletPSN3ecff825-34ea-4535-b935-627bf2c13d932
866514metoprolol tartrate 50 MG Oral TabletPSN3ecff825-34ea-4535-b935-627bf2c13d932
1606349metoprolol tartrate 75 MG Oral TabletPSN3ecff825-34ea-4535-b935-627bf2c13d932
866511metoprolol tartrate 100 MG Oral TabletSCD3ecff825-34ea-4535-b935-627bf2c13d932
866924metoprolol tartrate 25 MG Oral TabletSCD3ecff825-34ea-4535-b935-627bf2c13d932
1606347metoprolol tartrate 37.5 MG Oral TabletSCD3ecff825-34ea-4535-b935-627bf2c13d932
866514metoprolol tartrate 50 MG Oral TabletSCD3ecff825-34ea-4535-b935-627bf2c13d932
1606349metoprolol tartrate 75 MG Oral TabletSCD3ecff825-34ea-4535-b935-627bf2c13d932
866511metoprolol tartrate 100 MG Oral TabletPSNdf3492c3-b71a-40d8-838b-031ebca969d81
866924metoprolol tartrate 25 MG Oral TabletPSNdf3492c3-b71a-40d8-838b-031ebca969d81
1606347metoprolol tartrate 37.5 MG Oral TabletPSNdf3492c3-b71a-40d8-838b-031ebca969d81
866514metoprolol tartrate 50 MG Oral TabletPSNdf3492c3-b71a-40d8-838b-031ebca969d81
1606349metoprolol tartrate 75 MG Oral TabletPSNdf3492c3-b71a-40d8-838b-031ebca969d81
866511metoprolol tartrate 100 MG Oral TabletSCDdf3492c3-b71a-40d8-838b-031ebca969d81
866924metoprolol tartrate 25 MG Oral TabletSCDdf3492c3-b71a-40d8-838b-031ebca969d81
1606347metoprolol tartrate 37.5 MG Oral TabletSCDdf3492c3-b71a-40d8-838b-031ebca969d81
866514metoprolol tartrate 50 MG Oral TabletSCDdf3492c3-b71a-40d8-838b-031ebca969d81
1606349metoprolol tartrate 75 MG Oral TabletSCDdf3492c3-b71a-40d8-838b-031ebca969d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-211-0172888021101100 TABLET in 1 BOTTLE (72888-211-01) 100 tablet2024-07-26NoNoHistorical
72888-211-0572888021105500 TABLET in 1 BOTTLE (72888-211-05) 500 tablet2024-07-26NoNoHistorical