Dutoprol

Product NDC
59212-095
11-digit product format
592120095
Labeler code
59212
Product ID
59212-095_ab789dec-c39e-4dcf-9e51-618cc239dafc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Concordia Pharmaceuticals Inc.
Application
NDA021956
Marketing category
NDA
Marketing start
2014-07-01
Marketing end
2022-09-30
Substance
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
Active strength
13 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct59212-095DDiscontinued by firm2026-08-07
excluded packagepackage59212-09559212-095-30DDiscontinued by firm2026-08-07

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 packagepackage59212-095-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59212-095-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59212-095-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59212-095-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59212-095-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59212-095-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59212-095-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59212-095-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59212-095-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59212-095-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59212-095-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59212-095-30557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021956-001DUTOPROLHYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28
N021956-002DUTOPROLHYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28
N021956-003DUTOPROLHYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021956-002DUTOPROL12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021956-003DUTOPROL12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021956-001DUTOPROL12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-08-288072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-095-30EA - Each59212-0959f230610-26cb-453f-88d5-9313ba41e08d12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
METOPROLOLACTIVE MOIETYGEB06NHM23DUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
POVIDONE K15INACTIVE INGREDIENTE54VE15114DUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDUTOPROL (METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE) TABLET [CONCORDIA PHARMACEUTICALS INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-095-305921200953030 TABLET in 1 BOTTLE (59212-095-30) 30 tablet2014-07-012022-09-30NoNoCurrent