Metoprolol Tartrate

Product NDC
48433-312
11-digit product format
484330312
Labeler code
48433
Product ID
48433-312_12a9faa9-eb59-4b06-bbc0-7381f8526819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA074141
Marketing category
ANDA
Marketing start
2014-09-30
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct48433-312DDiscontinued by firm2026-08-17
excluded packagepackage48433-31248433-312-10DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage48433-312-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage48433-312-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage48433-312-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage48433-312-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage48433-312-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage48433-312-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage48433-312-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage48433-312-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage48433-312-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage48433-312-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage48433-312-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage48433-312-10557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074141-001METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31
A074141-002METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074141-001METOPROLOL TARTRATE50MGTABLET / ORALAB1995-01-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074141-002METOPROLOL TARTRATE100MGTABLET / ORALAB1995-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074141-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074141-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A074141-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074141-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074141-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074141-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074141-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074141-002AB1ea99ee380514…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933METOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82METOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMETOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1