Home NDC 52343-059 Metoprolol Tartrate
Product NDC 52343-059
11-digit product format 523430059
Labeler code 52343
Product ID 52343-059_6a59ebd2-3cb9-4b56-871b-47b84428aafb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ACETRIS HEALTH, LLC
Application ANDA077739
Marketing category ANDA
Marketing start 2007-09-11
Marketing end 0000-00-00
Substance METOPROLOL TARTRATE
Active strength 25 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077739-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 A077739-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 A077739-003 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 A077739-004 METOPROLOL TARTRATE METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 A077739-005 METOPROLOL TARTRATE METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 4 · 157 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 2026-02-19 14:30 UTC 2026-02 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 157 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPROLOL TARTRATE TABLET, FILM COATED [LUCID PHARMA LLC] 2 METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
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 3 of 3 · 41 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52343-059-01 52343005901 100 TABLET, FILM COATED in 1 BOTTLE (52343-059-01) 2007-09-11 0000-00-00 No No Current 52343-059-99 52343005999 1000 TABLET, FILM COATED in 1 BOTTLE (52343-059-99) 2007-09-11 0000-00-00 No No Current