Home NDC 82804-978-30 Metoprolol Tartrate
Product NDC 82804-978
Requested package NDC 82804-978-30
11-digit product format 828040978
Labeler code 82804
Product ID 82804-978_de781298-37cb-4c03-8431-b6d86ffbde0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA074453
Marketing category ANDA
Marketing start 2023-11-02
Substance METOPROLOL TARTRATE
Active strength 50 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074453-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 A074453-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 86 observed 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 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1995-04-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1995-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL 1995-04-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL 1995-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL 1995-04-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL 1995-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL 1995-04-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL 1995-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074453-001 METOPROLOL TARTRATE 50MG TABLET / ORAL 1995-04-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074453-002 METOPROLOL TARTRATE 100MG TABLET / ORAL 1995-04-27 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 50 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 866511 Internal RxNorm lookup 866514 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 82804-978-00 Metoprolol Tartrate 100 in 1 BOTTLE TABLET 100 1 82804-978-11 Metoprolol Tartrate 1000 in 1 BOTTLE TABLET 1000 1 82804-978-30 Metoprolol Tartrate 30 in 1 BOTTLE TABLET 30 1 82804-978-55 Metoprolol Tartrate 500 in 1 BOTTLE TABLET 500 1 82804-978-60 Metoprolol Tartrate 60 in 1 BOTTLE TABLET 60 1 82804-978-90 Metoprolol Tartrate 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-978 METOPROLOL TARTRATE TABLET [PROFICIENT RX LP] 1 Current NDC, 6 package rows 20250313_de781298-37cb-4c03-8431-b6d86ffbde0d.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-978-30 82804097830 30 TABLET in 1 BOTTLE (82804-978-30) 30 tablet 2025-03-11 No No Current