FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
72888-004
11-digit product format
728880004
Labeler code
72888
Product ID
72888-004_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
25 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 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
72888-004-00METOPROLOL TARTRATE1000 in 1 BOTTLETABLET, FILM COATED10006
72888-004-01METOPROLOL TARTRATE100 in 1 BOTTLETABLET, FILM COATED1006
72888-004-05METOPROLOL TARTRATE500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-004-00EA - Each72888-004a7bd2fae-64bd-45fd-9cc1-5102eebf24aa12021-07-15
72888-004-01EA - Each72888-004076c3a61-f8c1-4636-b217-0d3f485f09f912021-07-15
72888-004-05EA - Each72888-004422b5653-e357-490c-9224-d98003f46b9b12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-004METOPROLOL TARTRATE TABLET, FILM COATED [ADVAGEN PHARMA LIMITED]5Current NDC, Legacy NDC, 3 package rows20241224_a401fe31-d51a-49d9-a062-c9d22088db56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866924metoprolol tartrate 25 MG Oral TabletPSN840ac287-cae5-4c07-82d5-546fb04414ef105
866924metoprolol tartrate 25 MG Oral TabletSCD840ac287-cae5-4c07-82d5-546fb04414ef105
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
866924metoprolol tartrate 25 MG Oral TabletPSNfae7a662-9b27-4c5f-80b5-22442f0ae4365
866924metoprolol tartrate 25 MG Oral TabletSCDfae7a662-9b27-4c5f-80b5-22442f0ae4365
866924metoprolol tartrate 25 MG Oral TabletPSN35922e9c-6a4c-446a-8294-a4cd3f3f0d103
866924metoprolol tartrate 25 MG Oral TabletPSN2760fbbc-ec68-4df8-e063-6394a90a15f53
866924metoprolol tartrate 25 MG Oral TabletPSN09d23356-ddf9-4dbd-e063-6394a90a217a3
866924metoprolol tartrate 25 MG Oral TabletSCD35922e9c-6a4c-446a-8294-a4cd3f3f0d103
866924metoprolol tartrate 25 MG Oral TabletSCD2760fbbc-ec68-4df8-e063-6394a90a15f53
866924metoprolol tartrate 25 MG Oral TabletSCD09d23356-ddf9-4dbd-e063-6394a90a217a3
866924metoprolol tartrate 25 MG Oral TabletPSNfcb2812b-37d2-de88-e053-6394a90ac2b52
866924metoprolol tartrate 25 MG Oral TabletSCDfcb2812b-37d2-de88-e053-6394a90ac2b52
866924metoprolol tartrate 25 MG Oral TabletPSN1e1a8729-0673-9e8c-e063-6394a90a67301
866924metoprolol tartrate 25 MG Oral TabletPSN09d23031-3da8-50c7-e063-6394a90a25251
866924metoprolol tartrate 25 MG Oral TabletSCD1e1a8729-0673-9e8c-e063-6394a90a67301
866924metoprolol tartrate 25 MG Oral TabletSCD09d23031-3da8-50c7-e063-6394a90a25251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-004-00728880004001000 TABLET, FILM COATED in 1 BOTTLE (72888-004-00) 2024-10-180000-00-00NoNoCurrent
72888-004-0172888000401100 TABLET, FILM COATED in 1 BOTTLE (72888-004-01) 2024-10-180000-00-00NoNoCurrent
72888-004-0572888000405500 TABLET, FILM COATED in 1 BOTTLE (72888-004-05) 2024-10-180000-00-00NoNoCurrent