Home NDC 68645-191 Metoprolol Tartrate
Product NDC 68645-191
11-digit product format 686450191
Labeler code 68645
Product ID 68645-191_4cc30c1b-869a-e0fd-e063-6394a90a49ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Legacy Pharmaceutical Packaging, LLC
Application ANDA077739
Marketing category ANDA
Marketing start 2007-09-11
Marketing end 2027-07-31
Substance METOPROLOL TARTRATE
Active strength 100 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
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 · 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 5 · 167 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 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 167 observed states.
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 Active Ingredients# Ingredient, Strength table Ingredient Strength METOPROLOL TARTRATE 100 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 68645-191-59 Metoprolol Tartrate 60 in 1 BOTTLE TABLET, FILM COATED 60 14
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 [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68645-191 METOPROLOL TARTRATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 13 Current NDC, Legacy NDC, 1 package rows 20250425_20cc66c0-a00b-4643-9819-6e0daed51e5f.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 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 68645-191-59 68645019159 60 TABLET, FILM COATED in 1 BOTTLE (68645-191-59) 2007-09-11 2027-07-31 No No Current