Home NDC 72888-197-00 Metoprolol Tartrate
Product NDC 72888-197
Requested package NDC 72888-197-00
11-digit product format 728880197
Labeler code 72888
Product ID 72888-197_4984fefe-6924-2aa6-e063-6394a90a1853
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METOPROLOL TARTRATE
Dosage form TABLET
Route ORAL
Labeler Advagen Pharma Limited
Application NDA218698
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-08-28
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 Metoprolol Tartrate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2723025 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72888-197-00 Metoprolol Tartrate 1000 in 1 BOTTLE TABLET 1000 2 72888-197-03 Metoprolol Tartrate 60 in 1 BOTTLE TABLET 60 2 72888-197-30 Metoprolol Tartrate 30 in 1 BOTTLE TABLET 30 2
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 72888-197-00 72888019700 1000 TABLET in 1 BOTTLE (72888-197-00) 1000 tablet 2025-08-28 No No Current