Metoprolol Tartrate

Product NDC
55289-093
Requested package NDC
55289-093-93
11-digit product format
552890093
Labeler code
55289
Product ID
55289-093_adb868f9-bd13-1215-e053-2a95a90a34ff
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
100 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55289-09355289-093-93DDiscontinued 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 · 12 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…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
55289-093-30EA - Each55289-0930f5408a7-f261-414e-9c24-0adaa58e128b12012-07-24
55289-093-60EA - Each55289-093a7f1e10f-dc4e-4d2a-854d-53d96d07056f12012-07-24
55289-093-90EA - Each55289-09367e75bd0-353f-4144-8a6c-8e4945f88e8312012-07-24
55289-093-93EA - Each55289-093b0352d28-8c0f-4fd0-ae19-dc0d3d123b4412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-093-9355289009393180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-093-93) 2015-10-270000-00-00NoNoCurrent