FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
51655-514
11-digit product format
516550514
Labeler code
51655
Product ID
51655-514_490f8fd3-7545-fb69-e063-6294a90a8b21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077739
Marketing category
ANDA
Marketing start
2022-07-14
Substance
METOPROLOL TARTRATE
Active strength
100 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 TARTRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866511

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
51655-514-25Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
51655-514-26Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-514-52Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
51655-514-83Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-514METOPROLOL TARTRATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 4 package rows20240724_f318d14a-9f96-4238-e053-2995a90abc15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSNf318d14a-9f96-4238-e053-2995a90abc154
866511metoprolol tartrate 100 MG Oral TabletSCDf318d14a-9f96-4238-e053-2995a90abc154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-514-255165505142560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-514-25) 2022-07-14NoNoCurrent
51655-514-265165505142690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-514-26) 2023-04-07NoNoCurrent
51655-514-525165505145230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-514-52) 2022-08-08NoNoCurrent
51655-514-8351655051483180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-514-83) 2023-01-06NoNoCurrent