Home NDC 35356-889 Metoprolol Tartrate
Product NDC 35356-889
11-digit product format 353560889
Labeler code 35356
Product ID 35356-889_a2561b14-d410-4e94-bf53-d61235ba7ead
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol tartrate
Dosage form TABLET
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA074644
Marketing category ANDA
Marketing start 1997-07-01
Marketing end 0000-00-00
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 2019-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A074644-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 A074644-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10
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 · 88 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 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.