FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
62332-112
11-digit product format
623320112
Labeler code
62332
Product ID
62332-112_c7738f42-299e-4bea-af50-778e069352f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA202871
Marketing category
ANDA
Marketing start
2016-07-31
Substance
METOPROLOL TARTRATE
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866511, 866514, 866924

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-112-30METOPROLOL TARTRATE30 in 1 BOTTLETABLET3010
62332-112-31METOPROLOL TARTRATE100 in 1 BOTTLETABLET10010
62332-112-91METOPROLOL TARTRATE1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-112-31EA - Each62332-112d8e3a88d-4dc9-4408-a105-d3676af973b612016-03-04
62332-112-91EA - Each62332-1123ae89298-e3f5-4923-8e52-d00a3a11c56a12016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-112METOPROLOL TARTRATE (METOPROLOL) TABLET [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 3 package rows20241106_24837d82-0f3f-4482-9af0-31e5f675c30f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSNc97e7527-b44e-48ca-b6be-53999bf5554b11
866924metoprolol tartrate 25 MG Oral TabletPSNc97e7527-b44e-48ca-b6be-53999bf5554b11
866514metoprolol tartrate 50 MG Oral TabletPSNc97e7527-b44e-48ca-b6be-53999bf5554b11
866511metoprolol tartrate 100 MG Oral TabletSCDc97e7527-b44e-48ca-b6be-53999bf5554b11
866924metoprolol tartrate 25 MG Oral TabletSCDc97e7527-b44e-48ca-b6be-53999bf5554b11
866514metoprolol tartrate 50 MG Oral TabletSCDc97e7527-b44e-48ca-b6be-53999bf5554b11
866511metoprolol tartrate 100 MG Oral TabletPSN24837d82-0f3f-4482-9af0-31e5f675c30f10
866924metoprolol tartrate 25 MG Oral TabletPSN24837d82-0f3f-4482-9af0-31e5f675c30f10
866514metoprolol tartrate 50 MG Oral TabletPSN24837d82-0f3f-4482-9af0-31e5f675c30f10
866511metoprolol tartrate 100 MG Oral TabletSCD24837d82-0f3f-4482-9af0-31e5f675c30f10
866924metoprolol tartrate 25 MG Oral TabletSCD24837d82-0f3f-4482-9af0-31e5f675c30f10
866514metoprolol tartrate 50 MG Oral TabletSCD24837d82-0f3f-4482-9af0-31e5f675c30f10
866924metoprolol tartrate 25 MG Oral TabletPSN58d493d3-b69c-422a-b6a8-0f8fa1e555459
866924metoprolol tartrate 25 MG Oral TabletSCD58d493d3-b69c-422a-b6a8-0f8fa1e555459
866924metoprolol tartrate 25 MG Oral TabletPSN95b95aab-0733-4189-b4c0-429a1046c5344
866924metoprolol tartrate 25 MG Oral TabletSCD95b95aab-0733-4189-b4c0-429a1046c5344
866924metoprolol tartrate 25 MG Oral TabletPSN106b7a0c-af7f-2565-e063-6294a90a34e03
866924metoprolol tartrate 25 MG Oral TabletSCD106b7a0c-af7f-2565-e063-6294a90a34e03
866924metoprolol tartrate 25 MG Oral TabletPSN26ab0fad-678b-769d-e063-6394a90a43891
866924metoprolol tartrate 25 MG Oral TabletSCD26ab0fad-678b-769d-e063-6394a90a43891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-112-306233201123030 TABLET in 1 BOTTLE (62332-112-30) 30 tablet2016-07-310000-00-00NoNoCurrent
62332-112-3162332011231100 TABLET in 1 BOTTLE (62332-112-31) 100 tablet2016-07-310000-00-00NoNoCurrent
62332-112-91623320112911000 TABLET in 1 BOTTLE (62332-112-91) 1000 tablet2016-07-310000-00-00NoNoCurrent