FDA.reportPublic FDA data

LOPRESSOR

Product NDC
30698-460
11-digit product format
306980460
Labeler code
30698
Product ID
30698-460_494efa43-aa90-d6f4-e063-6294a90a11ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
VALIDUS PHARMACEUTICALS LLC
Application
NDA218698
Marketing category
NDA
Marketing start
2025-08-11
Substance
METOPROLOL TARTRATE
Active strength
12.5 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
LOPRESSOR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui2723025, 2723027

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30698-460-012024-01-30C16284748780-19855d018-d940-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LOPRESSOR HCT safely and effectively. See full prescribing information for LOPRESSOR HCT LOPRESSOR HCT (metoprolol tartrate and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1984
30698-460-012019-11-27C16284748780-19855d018-d940-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LOPRESSOR HCT safely and effectively. See full prescribing information for LOPRESSOR HCT LOPRESSOR HCT (metoprolol tartrate and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-460-01LOPRESSOR60 in 1 BOTTLETABLET603
30698-460-03LOPRESSOR30 in 1 BOTTLETABLET303
30698-460-10LOPRESSOR1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-460-01EA - Each30698-460d32e8b92-1bb0-49a2-be38-eaa050ec0c9012013-02-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723027Lopressor 12.5 MG Oral TabletPSNb5f4fed2-369c-4808-a682-8a5b8cfdbb4f3
2723025metoprolol tartrate 12.5 MG Oral TabletPSNb5f4fed2-369c-4808-a682-8a5b8cfdbb4f3
2723027metoprolol tartrate 12.5 MG Oral Tablet [Lopressor]SBDb5f4fed2-369c-4808-a682-8a5b8cfdbb4f3
2723025metoprolol tartrate 12.5 MG Oral TabletSCDb5f4fed2-369c-4808-a682-8a5b8cfdbb4f3
2723027Lopressor 12.5 MG Oral TabletSYb5f4fed2-369c-4808-a682-8a5b8cfdbb4f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
30698-460-013069804600160 TABLET in 1 BOTTLE (30698-460-01) 60 tablet2026-01-25NoNoCurrent
30698-460-033069804600330 TABLET in 1 BOTTLE (30698-460-03) 30 tablet2025-08-11NoNoCurrent
30698-460-10306980460101000 TABLET in 1 BOTTLE (30698-460-10) 1000 tablet2025-08-11NoNoCurrent