Home NDC 53808-1018 Metoprolol Tartrate
Product NDC 53808-1018
11-digit product format 538081018
Labeler code 53808
Product ID 53808-1018_b53f57c5-d13a-42c9-b385-a9b2f1af296d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoprolol Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA078459
Marketing category ANDA
Marketing start 2014-11-01
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 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-1018-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-1018-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-1018-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-1018-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-1018-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-1018-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-1018-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-1018-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-1018-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-1018-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-1018-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-1018-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-1018-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-1018-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-1018-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-1018-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-1018-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-1018-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-1018-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-1018-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-1018-1 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078459-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 A078459-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 A078459-003 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-1018-1 Metoprolol Tartrate 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOPROLOL TARTRATE ACTIVE INGREDIENT W5S57Y3A5L METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 METOPROLOL ACTIVE MOIETY GEB06NHM23 METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-1018 METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20150113_96361be5-6052-4409-9e43-c89cfd824a69.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-1018-1 53808101801 30 in 1 BLISTER PACK Historical