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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219373-001LOPRESSORMETOPROLOL TARTRATE10MG/MLSOLUTION / ORALRLD, RS2025-04-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N219373-001LOPRESSOR10MG/MLSOLUTION / ORALRLD, RS2025-04-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219373-001LOPRESSOR10MG/MLSOLUTION / ORALRLD, RS2025-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219373-001LOPRESSOR10MG/MLSOLUTION / ORALRLD, RS2025-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N219373-001LOPRESSOR10MG/MLSOLUTION / ORALRLD, RS2025-04-106a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219373-001LOPRESSOR10MG/MLSOLUTION / ORALRLD, RS2025-04-10a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W5S57Y3A5LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2712147Internal RxNorm lookup
2712152Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f448171-9588-4a54-88b3-5d870060ce86Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOPRESSORMETOPROLOL TARTRATEVALIDUS PHARMACEUTICALS LLC9f448171-9588-4a54-88b3-5d870060ce862025-05-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 219373
application number: NDA219373
ndc (product): 30698-464

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 bottle2025-04-11NoNoCurrent
30698-464-31306980464311 BOTTLE in 1 CARTON (30698-464-31) / 300 mL in 1 BOTTLE1 bottle2025-04-11NoNoCurrent