FDA.reportPublic FDA data

Metoprolol Tartrate and Hydrochlorothiazide

Product NDC
0378-0445
11-digit product format
003780445
Labeler code
0378
Product ID
0378-0445_2631c7b0-5af8-4967-b945-d3398b2147ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076792
Marketing category
ANDA
Marketing start
2004-08-20
Substance
METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE
Active strength
100; 50 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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE25MG;50MGTABLET / ORALAB2004-08-20
A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE25MG;100MGTABLET / ORALAB2004-08-20
A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE50MG;100MGTABLET / ORALABRS2004-08-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076792-001AB
A076792-002AB
A076792-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-20c2088c7a36db…
2026-10-15 13:18:302026-09A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-20c2088c7a36db…
2026-10-15 13:18:302026-09A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALABRS2004-08-20c2088c7a36db…
2026-09-14 22:38:342026-08A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-2084e616aacf4f…
2026-09-14 22:38:342026-08A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-2084e616aacf4f…
2026-09-14 22:38:342026-08A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALABRS2004-08-2084e616aacf4f…
2026-08-18 06:07:402026-07A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALABRS2004-08-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-2079d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-10-28 04:53 UTC2022-10A076792-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A076792-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A076792-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076792-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A076792-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A076792-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076792-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076792-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076792-003AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076792-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076792-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076792-003AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE100 mg/1
HYDROCHLOROTHIAZIDE50 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0445-01Metoprolol Tartrate and Hydrochlorothiazide100 in 1 BOTTLE, PLASTICTABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0445-01EA - Each0378-0445ecf44bbc-9ffd-4e4f-a1bb-9010f9a745a612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0445METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 1 package rows20240413_b6cf0f43-8dc3-4535-b651-daf1f9e0336c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866479metoprolol tartrate 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNb6cf0f43-8dc3-4535-b651-daf1f9e0336c12
866491metoprolol tartrate 100 MG / hydroCHLOROthiazide 50 MG Oral TabletPSNb6cf0f43-8dc3-4535-b651-daf1f9e0336c12
866482metoprolol tartrate 50 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNb6cf0f43-8dc3-4535-b651-daf1f9e0336c12
866479hydrochlorothiazide 25 MG / metoprolol tartrate 100 MG Oral TabletSCDb6cf0f43-8dc3-4535-b651-daf1f9e0336c12
866482hydrochlorothiazide 25 MG / metoprolol tartrate 50 MG Oral TabletSCDb6cf0f43-8dc3-4535-b651-daf1f9e0336c12
866491hydrochlorothiazide 50 MG / metoprolol tartrate 100 MG Oral TabletSCDb6cf0f43-8dc3-4535-b651-daf1f9e0336c12
866479HCTZ 25 MG / metoprolol tartrate 100 MG Oral TabletSYb6cf0f43-8dc3-4535-b651-daf1f9e0336c12
866482HCTZ 25 MG / metoprolol tartrate 50 MG Oral TabletSYb6cf0f43-8dc3-4535-b651-daf1f9e0336c12
866491HCTZ 50 MG / metoprolol tartrate 100 MG Oral TabletSYb6cf0f43-8dc3-4535-b651-daf1f9e0336c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0445-0100378044501100 TABLET in 1 BOTTLE, PLASTIC (0378-0445-01) 100 tablet2004-08-200000-00-00NoNoCurrent