Home NDC 43063-821 Metoprolol Tartrate
Product NDC 43063-821
11-digit product format 430630821
Labeler code 43063
Product ID 43063-821_47cee106-d10c-fb07-e063-6294a90ac517
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA077739
Marketing category ANDA
Marketing start 2007-09-11
Marketing end 2027-08-31
Substance METOPROLOL TARTRATE
Active strength 50 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 44 .
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 · 172 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 2026-10-15 13:18:30 2026-09 A077739-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2007-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077739-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2007-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077739-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2007-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077739-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2023-12-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077739-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2023-12-07 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 43063-821-30 Metoprolol Tartrate 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 30 43063-821-60 Metoprolol Tartrate 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 30 43063-821-90 Metoprolol Tartrate 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 30 43063-821-93 Metoprolol Tartrate 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 30
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-821 METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 27 Current NDC, Legacy NDC, 4 package rows 20240703_19678edf-934a-45f3-b5da-94d10e9b3248.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 43063-821-30 43063082130 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-30) 2018-06-27 2027-08-31 No No Current 43063-821-60 43063082160 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-60) 2018-05-17 2027-08-31 No No Current 43063-821-90 43063082190 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-90) 2017-01-05 2027-08-31 No No Current 43063-821-93 43063082193 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-93) 2017-01-05 2027-08-31 No No Current