Metoprolol Tartrate

Product NDC
43063-064
11-digit product format
430630064
Labeler code
43063
Product ID
43063-064_adbac240-caf1-9281-e053-2995a90a3433
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA074217
Marketing category
ANDA
Marketing start
1994-05-27
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
2021-12-31
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 productproduct43063-064DDiscontinued by firm2026-08-17
excluded packagepackage43063-06443063-064-06DDiscontinued 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 packagepackage43063-064-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-064-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-064-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-064-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-064-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-064-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-064-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-064-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-064-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43063-064-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43063-064-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43063-064-06557ba5c1ecfa…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
A074217-001METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27
A074217-002METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27

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 06:07:402026-07A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A074217-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074217-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074217-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074217-002AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-064-06EA - Each43063-06495185c90-2b58-4c59-8dc2-4c51108ae22012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-064-06430630064066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-064-06) 2010-08-100000-00-00NoNoCurrent