FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
68788-8840
11-digit product format
687888840
Labeler code
68788
Product ID
68788-8840_3ced6d8c-8a88-47dc-9f11-dddbd4c31609
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA200981
Marketing category
ANDA
Marketing start
2025-03-06
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
68788-8840-1METOPROLOL TARTRATE100 in 1 BOTTLETABLET1001
68788-8840-3METOPROLOL TARTRATE30 in 1 BOTTLETABLET301
68788-8840-6METOPROLOL TARTRATE60 in 1 BOTTLETABLET601
68788-8840-9METOPROLOL TARTRATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8840-1EA - Each68788-88407b9df05e-7196-4c65-8e96-13e4486969b412025-05-14
68788-8840-3EA - Each68788-8840bc0f2d32-b3f0-42aa-a7cf-dd89de6913bb12025-05-14
68788-8840-6EA - Each68788-8840188ae354-2c3e-41a8-8d9f-b5e5f5d32b9812025-05-14
68788-8840-9EA - Each68788-8840efa67082-0078-4806-8f86-78432dc7d4f712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8840METOPROLOL TARTRATE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20250309_3ced6d8c-8a88-47dc-9f11-dddbd4c31609.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866924metoprolol tartrate 25 MG Oral TabletPSN3ced6d8c-8a88-47dc-9f11-dddbd4c316091
866924metoprolol tartrate 25 MG Oral TabletSCD3ced6d8c-8a88-47dc-9f11-dddbd4c316091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8840-168788884001100 TABLET in 1 BOTTLE (68788-8840-1) 100 tablet2025-03-06NoNoHistorical
68788-8840-36878888400330 TABLET in 1 BOTTLE (68788-8840-3) 30 tablet2025-03-06NoNoHistorical
68788-8840-66878888400660 TABLET in 1 BOTTLE (68788-8840-6) 60 tablet2025-03-06NoNoHistorical
68788-8840-96878888400990 TABLET in 1 BOTTLE (68788-8840-9) 90 tablet2025-03-06NoNoHistorical