Metoprolol Tartrate and Hydrochlorothiazide

Product NDC
62756-368
11-digit product format
627560368
Labeler code
62756
Product ID
62756-368_99595af6-8c5d-4dc7-8396-e7bce050bb3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090654
Marketing category
ANDA
Marketing start
2022-04-01
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1
METOPROLOL TARTRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L, 0J48LPH2TH
Rxcui866479, 866482, 866491

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
62756-368-08Metoprolol Tartrate and Hydrochlorothiazide100 in 1 BOTTLETABLET10010
62756-368-18Metoprolol Tartrate and Hydrochlorothiazide1000 in 1 BOTTLETABLET100010
62756-368-83Metoprolol Tartrate and Hydrochlorothiazide30 in 1 BOTTLETABLET3010
62756-368-88Metoprolol Tartrate and Hydrochlorothiazide100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-368-88EA - Each62756-36839ee5a92-d38a-4dd6-8f39-daecfc95dd9112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-368METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 4 package rows20240120_faaf13ce-5d8d-4c57-a49f-a7a73daa41a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866479metoprolol tartrate 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510
866491metoprolol tartrate 100 MG / hydroCHLOROthiazide 50 MG Oral TabletPSNfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510
866482metoprolol tartrate 50 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510
866479hydrochlorothiazide 25 MG / metoprolol tartrate 100 MG Oral TabletSCDfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510
866482hydrochlorothiazide 25 MG / metoprolol tartrate 50 MG Oral TabletSCDfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510
866491hydrochlorothiazide 50 MG / metoprolol tartrate 100 MG Oral TabletSCDfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510
866479HCTZ 25 MG / metoprolol tartrate 100 MG Oral TabletSYfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510
866482HCTZ 25 MG / metoprolol tartrate 50 MG Oral TabletSYfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510
866491HCTZ 50 MG / metoprolol tartrate 100 MG Oral TabletSYfaaf13ce-5d8d-4c57-a49f-a7a73daa41a510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-368-0862756036808100 TABLET in 1 BOTTLE (62756-368-08) 100 tablet2022-04-010000-00-00NoNoCurrent
62756-368-18627560368181000 TABLET in 1 BOTTLE (62756-368-18) 1000 tablet2022-04-010000-00-00NoNoCurrent
62756-368-836275603688330 TABLET in 1 BOTTLE (62756-368-83) 30 tablet2022-04-010000-00-00NoNoCurrent
62756-368-8862756036888100 TABLET in 1 BOTTLE (62756-368-88) 100 tablet2022-04-010000-00-00NoNoCurrent