Home NDC 30698-460-03 LOPRESSOR
Product NDC 30698-460
Requested package NDC 30698-460-03
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218698-001 LOPRESSOR METOPROLOL TARTRATE 12.5MG TABLET / ORAL RLD, RS 2025-08-28
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N218698-001 LOPRESSOR 12.5MG TABLET / ORAL RLD, RS 2025-08-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218698-001 LOPRESSOR 12.5MG TABLET / ORAL RLD, RS 2025-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218698-001 LOPRESSOR 12.5MG TABLET / ORAL RLD, RS 2025-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218698-001 LOPRESSOR 12.5MG TABLET / ORAL RLD, RS 2025-08-28 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218698-001 LOPRESSOR 12.5MG TABLET / ORAL RLD, RS 2025-08-28 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LOPRESSOR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOPROLOL TARTRATE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W5S57Y3A5L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2723025 Internal RxNorm lookup 2723027 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30698-460-01 LOPRESSOR 60 in 1 BOTTLE TABLET 60 3 30698-460-03 LOPRESSOR 30 in 1 BOTTLE TABLET 30 3 30698-460-10 LOPRESSOR 1000 in 1 BOTTLE TABLET 1000 3
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 30698-460-03 30698046003 30 TABLET in 1 BOTTLE (30698-460-03) 30 tablet 2025-08-11 No No Current