Home NDC 0615-3553 Metoprolol Tartrate
Product NDC 0615-3553
11-digit product format 006153553
Labeler code 0615
Product ID 0615-3553_2f6b97a8-7121-4bc7-9cd5-72d7f8ec8ef3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol tartrate
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA074644
Marketing category ANDA
Marketing start 1997-07-01
Marketing end 0000-00-00
Substance METOPROLOL TARTRATE
Active strength 100 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-3553-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-3553-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-3553-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-3553-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-3553-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-3553-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-3553-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-3553-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-3553-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-3553-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-3553-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-3553-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-3553-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-3553-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-3553-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-3553-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-3553-30 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-3553-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-3553-30 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-3553-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-3553-30 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-3553-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-3553-30 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-3553-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-3553-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-3553-30 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-3553-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-3553-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-3553-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-3553-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 2026-08-18 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…2019-12-13 00:20 UTC 2019-12 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074644-001 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 1996-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074644-002 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 1996-12-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 POVIDONES INACTIVE INGREDIENT FZ989GH94E METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPROLOL TARTRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11