FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
43063-821
11-digit product format
430630821
Labeler code
43063
Product ID
43063-821_47cee106-d10c-fb07-e063-6294a90ac517
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
Marketing end
2027-08-31
Substance
METOPROLOL TARTRATE
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866514

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
43063-821-30Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3030
43063-821-60Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6030
43063-821-90Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9030
43063-821-93Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-821-30EA - Each43063-821f8deece7-6783-4d3e-ba20-20e07d9e11ab12018-08-13
43063-821-60EA - Each43063-821db593fe6-80e0-44ff-8c6f-25977bd9093c12018-07-03
43063-821-90EA - Each43063-82106a91e35-6e65-4a7a-9990-350b32c22d3f12018-02-20
43063-821-93EA - Each43063-8216ce0a499-da19-449b-83ec-3debe96a764612018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-821METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 4 package rows20240703_19678edf-934a-45f3-b5da-94d10e9b3248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866514metoprolol tartrate 50 MG Oral TabletPSN19678edf-934a-45f3-b5da-94d10e9b324830
866514metoprolol tartrate 50 MG Oral TabletSCD19678edf-934a-45f3-b5da-94d10e9b324830

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-821-304306308213030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-30) 2018-06-272027-08-31NoNoCurrent
43063-821-604306308216060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-60) 2018-05-172027-08-31NoNoCurrent
43063-821-904306308219090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-90) 2017-01-052027-08-31NoNoCurrent
43063-821-9343063082193180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-93) 2017-01-052027-08-31NoNoCurrent