Metoprolol Tartrate

Product NDC
49999-575
Requested package NDC
49999-575-90
11-digit product format
499990575
Labeler code
49999
Product ID
49999-575_65d3db02-1108-4c72-99c9-cdb1b7414229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA076670
Marketing category
ANDA
Marketing start
2004-01-15
Marketing end
0000-00-00
Substance
METOPROLOL TARTRATE
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49999-57549999-575-90DDiscontinued by firm2026-08-11

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076670-001METOPROLOL TARTRATEMETOPROLOL TARTRATE25MGTABLET / ORAL2004-01-15

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076670-001METOPROLOL TARTRATE25MGTABLET / ORAL2004-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORAL2004-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076670-001METOPROLOL TARTRATE25MGTABLET / ORAL2004-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-153f01610625f2…
2019-09-15 20:21 UTC2019-09A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076670-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076670-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076670-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076670-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076670-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076670-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076670-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076670-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076670-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076670-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076670-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076670-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076670-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076670-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076670-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076670-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076670-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076670-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076670-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076670-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076670-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076670-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076670-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076670-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076670-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076670-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076670-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076670-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076670-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076670-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076670-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076670-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076670-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076670-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076670-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076670-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076670-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076670-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-575-10EA - Each49999-5754494c6c7-c408-4683-868b-2c8647af371c12013-02-13
49999-575-20EA - Each49999-575f4ba41b1-4d8d-4eed-82db-cf3a38e12b2512013-02-13
49999-575-30EA - Each49999-575ece79e11-c4ff-45e2-a20c-1014a8dfc64612013-02-13
49999-575-60EA - Each49999-5758413a7ce-5a62-49ac-aea5-922080ba914a12013-05-02
49999-575-90EA - Each49999-575edecc0a6-16db-402b-8ea8-7e9bdf1aa80c12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3954

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-575-904999905759090 TABLET in 1 BOTTLE (49999-575-90) 90 tablet2004-01-150000-00-00NoNoCurrent