FDA.reportPublic FDA data

LOPRESSOR

Product NDC
30698-464
11-digit product format
306980464
Labeler code
30698
Product ID
30698-464_352cee93-db0d-1c05-e063-6294a90a7533
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
SOLUTION
Route
ORAL
Labeler
VALIDUS PHARMACEUTICALS LLC
Application
NDA219373
Marketing category
NDA
Marketing start
2025-04-11
Substance
METOPROLOL TARTRATE
Active strength
10 mg/mL
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
LOPRESSOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui2712147, 2712152

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
30698-464-30LOPRESSOR1 in 1 CARTONSOLUTION13
30698-464-30LOPRESSOR300 mL in 1 BOTTLESOLUTION3003
30698-464-31LOPRESSOR300 mL in 1 BOTTLESOLUTION3003
30698-464-31LOPRESSOR1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-464-30ML - Milliliter30698-46492c9d5f0-bfd3-424a-87ad-2749965b158c12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-464LOPRESSOR (METOPROLOL TARTRATE) SOLUTION [VALIDUS PHARMACEUTICALS LLC]3Current NDC, 4 package rows20250516_9f448171-9588-4a54-88b3-5d870060ce86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2712152Lopressor 10 MG in 1 mL Oral SolutionPSN9f448171-9588-4a54-88b3-5d870060ce863
2712147metoprolol tartrate 10 MG in 1 mL Oral SolutionPSN9f448171-9588-4a54-88b3-5d870060ce863
2712152metoprolol tartrate 10 MG/ML Oral Solution [Lopressor]SBD9f448171-9588-4a54-88b3-5d870060ce863
2712147metoprolol tartrate 10 MG/ML Oral SolutionSCD9f448171-9588-4a54-88b3-5d870060ce863
2712152Lopressor 10 MG per 1 ML Oral SolutionSY9f448171-9588-4a54-88b3-5d870060ce863
2712147metoprolol tartrate 10 MG per 1 ML Oral SolutionSY9f448171-9588-4a54-88b3-5d870060ce863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
30698-464-30306980464301 BOTTLE in 1 CARTON (30698-464-30) / 300 mL in 1 BOTTLE1 bottle2025-04-11NoNoHistorical
30698-464-31306980464311 BOTTLE in 1 CARTON (30698-464-31) / 300 mL in 1 BOTTLE1 bottle2025-04-11NoNoHistorical