FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
43063-927
11-digit product format
430630927
Labeler code
43063
Product ID
43063-927_3739dcda-d80d-94c4-e063-6394a90a1dc6
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
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
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
43063-927-01Metoprolol Tartrate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10022
43063-927-14Metoprolol Tartrate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1422
43063-927-30Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022
43063-927-60Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6022
43063-927-90Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9022
43063-927-93Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-927-01EA - Each43063-927721cee08-6fdb-4b3d-9b6b-683ebbe41b7c12019-11-12
43063-927-14EA - Each43063-927b1af822a-0a47-467b-a7d9-901c57f6b75e12020-05-08
43063-927-30EA - Each43063-927fa713ea8-4e98-4882-b133-0eec384966ee12019-11-12
43063-927-60EA - Each43063-927a6d9fc05-4ac7-4436-9b54-a553a6f3cd3412019-05-02
43063-927-90EA - Each43063-927c4b26a2c-e744-46e0-a25f-f71193e7c86912019-03-12
43063-927-93EA - Each43063-927f2a47ff9-6f14-4380-9d6b-c11e8018399812019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-927METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 6 package rows20240704_00de1f16-f979-4dbf-aa60-246ffac8d410.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866924metoprolol tartrate 25 MG Oral TabletPSN00de1f16-f979-4dbf-aa60-246ffac8d41022
866924metoprolol tartrate 25 MG Oral TabletSCD00de1f16-f979-4dbf-aa60-246ffac8d41022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-927-0143063092701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-927-01) 2019-10-090000-00-00NoNoCurrent
43063-927-144306309271414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-927-14) 2019-03-170000-00-00NoNoCurrent
43063-927-304306309273030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-927-30) 2019-10-100000-00-00NoNoCurrent
43063-927-604306309276060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-927-60) 2019-03-280000-00-00NoNoCurrent
43063-927-904306309279090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-927-90) 2019-01-240000-00-00NoNoCurrent
43063-927-9343063092793180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-927-93) 2019-10-080000-00-00NoNoCurrent