FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
52817-250
11-digit product format
528170250
Labeler code
52817
Product ID
52817-250_2261de1d-98d7-8d12-e063-6394a90a33b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
TRUPHARMA LLC
Application
ANDA200981
Marketing category
ANDA
Marketing start
2024-01-17
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
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
52817-250-00METOPROLOL TARTRATE1000 in 1 BOTTLETABLET10001
52817-250-10METOPROLOL TARTRATE100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-250METOPROLOL TARTRATE TABLET [TRUPHARMA LLC]1Current NDC, 2 package rows20240920_92ab5942-823d-43aa-8e7a-56844ab8946f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN92ab5942-823d-43aa-8e7a-56844ab8946f1
866924metoprolol tartrate 25 MG Oral TabletPSN3eee00d8-8606-e6bb-e063-6394a90a4a1e1
866924metoprolol tartrate 25 MG Oral TabletPSN7ac58d12-58bf-470d-8a5a-01a18c0c92091
866924metoprolol tartrate 25 MG Oral TabletPSN92ab5942-823d-43aa-8e7a-56844ab8946f1
866924metoprolol tartrate 25 MG Oral TabletPSNd124cdfe-8250-41c1-badb-874b1060f7351
1606347metoprolol tartrate 37.5 MG Oral TabletPSN92ab5942-823d-43aa-8e7a-56844ab8946f1
866514metoprolol tartrate 50 MG Oral TabletPSN92ab5942-823d-43aa-8e7a-56844ab8946f1
1606349metoprolol tartrate 75 MG Oral TabletPSN92ab5942-823d-43aa-8e7a-56844ab8946f1
866511metoprolol tartrate 100 MG Oral TabletSCD92ab5942-823d-43aa-8e7a-56844ab8946f1
866924metoprolol tartrate 25 MG Oral TabletSCD3eee00d8-8606-e6bb-e063-6394a90a4a1e1
866924metoprolol tartrate 25 MG Oral TabletSCD7ac58d12-58bf-470d-8a5a-01a18c0c92091
866924metoprolol tartrate 25 MG Oral TabletSCD92ab5942-823d-43aa-8e7a-56844ab8946f1
866924metoprolol tartrate 25 MG Oral TabletSCDd124cdfe-8250-41c1-badb-874b1060f7351
1606347metoprolol tartrate 37.5 MG Oral TabletSCD92ab5942-823d-43aa-8e7a-56844ab8946f1
866514metoprolol tartrate 50 MG Oral TabletSCD92ab5942-823d-43aa-8e7a-56844ab8946f1
1606349metoprolol tartrate 75 MG Oral TabletSCD92ab5942-823d-43aa-8e7a-56844ab8946f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52817-250-00528170250001000 TABLET in 1 BOTTLE (52817-250-00) 1000 tablet2024-08-30NoNoCurrent
52817-250-1052817025010100 TABLET in 1 BOTTLE (52817-250-10) 100 tablet2024-08-30NoNoCurrent