Home NDC 76282-795 METOPROLOL TARTRATE
Product NDC 76282-795
11-digit product format 762820795
Labeler code 76282
Product ID 76282-795_562ee54a-9c4d-4677-9b0b-bc3bdd2809bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METOPROLOL TARTRATE
Dosage form TABLET
Route ORAL
Labeler Exelan Pharmaceuticals, Inc.
Application ANDA200981
Marketing category ANDA
Marketing start 2026-02-09
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200981-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 A200981-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 A200981-003 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 A200981-004 METOPROLOL TARTRATE METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 A200981-005 METOPROLOL TARTRATE METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21
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 6 · 211 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 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-004 METOPROLOL TARTRATE 37.5MG TABLET / ORAL AB 2019-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200981-005 METOPROLOL TARTRATE 75MG TABLET / ORAL AB 2019-08-21 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 211 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
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866511 Internal RxNorm lookup 866514 Internal RxNorm lookup 866924 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 76282-795-01 METOPROLOL TARTRATE 100 in 1 BOTTLE TABLET 100 2 76282-795-10 METOPROLOL TARTRATE 1000 in 1 BOTTLE TABLET 1000 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 5 of 5 · 82 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 76282-795-01 76282079501 100 TABLET in 1 BOTTLE (76282-795-01) 100 tablet 2026-02-09 No No Current 76282-795-10 76282079510 1000 TABLET in 1 BOTTLE (76282-795-10) 1000 tablet 2026-02-09 No No Current