FDA.reportPublic FDA data

Metoprolol Tartrate and Hydrochlorothiazide

Product NDC
0378-0434
11-digit product format
003780434
Labeler code
0378
Product ID
0378-0434_771d61ce-0810-4998-b77b-9d3fe58056d9
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
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Active strength
25; 100 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
2026-12-31
Current FDA listing
Yes

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
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 · 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 UTC2026-02A076792-001METOPROLOL 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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076792-002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2004-08-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076792-003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE50MG;100MGTABLET / ORALAB2004-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076792-001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE25MG;50MGTABLET / ORALAB2004-08-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076792-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076792-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076792-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076792-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076792-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076792-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076792-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076792-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076792-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076792-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076792-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076792-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076792-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076792-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076792-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076792-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076792-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076792-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076792-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076792-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076792-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076792-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076792-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076792-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076792-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076792-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076792-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076792-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076792-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076792-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076792-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076792-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076792-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076792-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076792-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076792-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076792-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076792-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076792-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076792-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE25 mg/1
HYDROCHLOROTHIAZIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup
W5S57Y3A5LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866479Internal RxNorm lookup
866482Internal RxNorm lookup
866491Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6cf0f43-8dc3-4535-b651-daf1f9e0336cAvailable on FDA.report

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
0378-0434-01Metoprolol Tartrate and Hydrochlorothiazide100 in 1 BOTTLE, PLASTICTABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0434-01EA - Each0378-04345580a1e2-28b1-471d-80a6-79a52744fefb12012-07-24

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
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0434METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 1 package rows20240413_b6cf0f43-8dc3-4535-b651-daf1f9e0336c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol Tartrate and HydrochlorothiazideMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.b6cf0f43-8dc3-4535-b651-daf1f9e0336c2024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076792
application number: ANDA076792
ndc (product): 0378-0434

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
866479metoprolol tartrate 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN67a67718-e59f-4988-8bfc-9b4ac103e3701
866482metoprolol tartrate 50 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN67a67718-e59f-4988-8bfc-9b4ac103e3701
866479hydrochlorothiazide 25 MG / metoprolol tartrate 100 MG Oral TabletSCD67a67718-e59f-4988-8bfc-9b4ac103e3701
866482hydrochlorothiazide 25 MG / metoprolol tartrate 50 MG Oral TabletSCD67a67718-e59f-4988-8bfc-9b4ac103e3701
866479HCTZ 25 MG / metoprolol tartrate 100 MG Oral TabletSY67a67718-e59f-4988-8bfc-9b4ac103e3701
866482HCTZ 25 MG / metoprolol tartrate 50 MG Oral TabletSY67a67718-e59f-4988-8bfc-9b4ac103e3701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0434-0100378043401100 TABLET in 1 BOTTLE, PLASTIC (0378-0434-01) 100 tablet2004-08-200000-00-00NoNoCurrent