FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
0378-0047
11-digit product format
003780047
Labeler code
0378
Product ID
0378-0047_57d60035-d408-4f98-932e-2cbbeae5326c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076704
Marketing category
ANDA
Marketing start
1993-12-23
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
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 TARTRATE100 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
0378-0047-01Metoprolol Tartrate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10031
0378-0047-10Metoprolol Tartrate1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0047METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy NDC, 2 package rows20240302_809c6386-0039-42ff-a03e-e42733e229b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866924metoprolol tartrate 25 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
1606347metoprolol tartrate 37.5 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866514metoprolol tartrate 50 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
1606349metoprolol tartrate 75 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866511metoprolol tartrate 100 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
866924metoprolol tartrate 25 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
1606347metoprolol tartrate 37.5 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
866514metoprolol tartrate 50 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
1606349metoprolol tartrate 75 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
866511metoprolol tartrate 100 MG Oral TabletPSNbec7ccad-00ad-4a3b-e053-2995a90ae3d85
866924metoprolol tartrate 25 MG Oral TabletPSNbec7ccad-00ad-4a3b-e053-2995a90ae3d85
866514metoprolol tartrate 50 MG Oral TabletPSNbec7ccad-00ad-4a3b-e053-2995a90ae3d85
866511metoprolol tartrate 100 MG Oral TabletSCDbec7ccad-00ad-4a3b-e053-2995a90ae3d85
866924metoprolol tartrate 25 MG Oral TabletSCDbec7ccad-00ad-4a3b-e053-2995a90ae3d85
866514metoprolol tartrate 50 MG Oral TabletSCDbec7ccad-00ad-4a3b-e053-2995a90ae3d85
866511metoprolol tartrate 100 MG Oral TabletPSN3859effa-7b9b-41cd-9c90-847fa99e9b342
866924metoprolol tartrate 25 MG Oral TabletPSN3859effa-7b9b-41cd-9c90-847fa99e9b342
866514metoprolol tartrate 50 MG Oral TabletPSN3859effa-7b9b-41cd-9c90-847fa99e9b342
866511metoprolol tartrate 100 MG Oral TabletSCD3859effa-7b9b-41cd-9c90-847fa99e9b342
866924metoprolol tartrate 25 MG Oral TabletSCD3859effa-7b9b-41cd-9c90-847fa99e9b342
866514metoprolol tartrate 50 MG Oral TabletSCD3859effa-7b9b-41cd-9c90-847fa99e9b342
866511metoprolol tartrate 100 MG Oral TabletPSN17ed5d5c-074f-4a59-bde6-209b3df872211
866924metoprolol tartrate 25 MG Oral TabletPSN17ed5d5c-074f-4a59-bde6-209b3df872211
866514metoprolol tartrate 50 MG Oral TabletPSN17ed5d5c-074f-4a59-bde6-209b3df872211
866511metoprolol tartrate 100 MG Oral TabletSCD17ed5d5c-074f-4a59-bde6-209b3df872211
866924metoprolol tartrate 25 MG Oral TabletSCD17ed5d5c-074f-4a59-bde6-209b3df872211
866514metoprolol tartrate 50 MG Oral TabletSCD17ed5d5c-074f-4a59-bde6-209b3df872211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0047-0100378004701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-01) 1993-12-230000-00-00NoNoCurrent
0378-0047-10003780047101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-10) 1993-12-230000-00-00NoNoCurrent
0378-0047-110037800471127586 TABLET, FILM COATED in 1 CONTAINER (0378-0047-11)18-OCT-22Current