FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
43063-938
11-digit product format
430630938
Labeler code
43063
Product ID
43063-938_415ead07-5bf7-51fc-e063-6294a90a4c4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077739
Marketing category
ANDA
Marketing start
2007-09-11
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

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
43063-938-30Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018
43063-938-60Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6018
43063-938-90Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9018
43063-938-93Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-938-30EA - Each43063-938c36b3fb3-b254-4a93-9cab-e4c7fab8ac9512019-07-02
43063-938-60EA - Each43063-938829aa066-0585-4102-a074-3aa4fab88c8312019-04-11
43063-938-90EA - Each43063-9384cbb5ebb-2faf-4e3b-8ba5-160fbdfd6ccb12019-03-12
43063-938-93EA - Each43063-938e73be6a2-4b36-425a-9c99-5c941202975712019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-938METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 4 package rows20240704_f4a4da81-c4d0-4a00-9f08-9029b5d9b5ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSNf4a4da81-c4d0-4a00-9f08-9029b5d9b5ea18
866511metoprolol tartrate 100 MG Oral TabletSCDf4a4da81-c4d0-4a00-9f08-9029b5d9b5ea18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-938-304306309383030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-938-30) 2019-05-130000-00-00NoNoCurrent
43063-938-604306309386060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-938-60) 2019-03-160000-00-00NoNoCurrent
43063-938-904306309389090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-938-90) 2019-01-290000-00-00NoNoCurrent
43063-938-9343063093893180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-938-93) 2019-01-290000-00-00NoNoCurrent