Metoprolol Tartrate

Product NDC
35356-782
11-digit product format
353560782
Labeler code
35356
Product ID
35356-782_ca19c119-50b6-4e15-a8bd-d8e4cd15976c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
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
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35356-782DDiscontinued by firm2026-08-17
excluded packagepackage35356-78235356-782-30DDiscontinued by firm2026-08-17
excluded packagepackage35356-78235356-782-60DDiscontinued by firm2026-08-17
excluded packagepackage35356-78235356-782-90DDiscontinued 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 · 48 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 packagepackage35356-782-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-782-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-782-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-782-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-782-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-782-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-782-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-782-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-782-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-782-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-782-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-782-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-782-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-782-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-782-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-782-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-782-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-782-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-782-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-782-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-782-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-782-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-782-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-782-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-782-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-782-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-782-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-782-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-782-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-782-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-782-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-782-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-782-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-782-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-782-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-782-90557ba5c1ecfa…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
A074644-001METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10
A074644-002METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074644-001AB
A074644-002AB

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 06:07:402026-07A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074644-001METOPROLOL TARTRATE50MGTABLET / ORALAB1996-12-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074644-002METOPROLOL TARTRATE100MGTABLET / ORALAB1996-12-10bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074644-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074644-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074644-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074644-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074644-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074644-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074644-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074644-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074644-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074644-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074644-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074644-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074644-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074644-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074644-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074644-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074644-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074644-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074644-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074644-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074644-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074644-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074644-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074644-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074644-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074644-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074644-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074644-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074644-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074644-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074644-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074644-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074644-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074644-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074644-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074644-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074644-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074644-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074644-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074644-002AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-782-30EA - Each35356-7822196bda8-c685-4422-a94f-ef6f267c503412013-06-04
35356-782-60EA - Each35356-7826e964b00-9667-4d4b-9d48-ea5cfef4f58912013-09-04
35356-782-90EA - Each35356-7827f1f8289-273d-4a0b-b900-08bbe30bdb2d12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-782-903535607829090 TABLET in 1 BOTTLE (35356-782-90) 90 tablet1997-07-010000-00-00NoNoCurrent