Metoprolol Tartrate

Product NDC
46708-112
11-digit product format
467080112
Labeler code
46708
Product ID
46708-112_23c75a4d-b479-4f77-ae48-ce9750fa2e1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA202871
Marketing category
ANDA
Marketing start
2014-03-14
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-112-10Metoprolol Tartrate100 in 1 BLISTER PACKTABLET1007
46708-112-30Metoprolol Tartrate30 in 1 BOTTLETABLET307
46708-112-31Metoprolol Tartrate100 in 1 BOTTLETABLET1007
46708-112-91Metoprolol Tartrate1000 in 1 BOTTLETABLET10007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-112METOPROLOL TARTRATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]7Legacy NDC, 4 package rows20150304_96ee7ca8-3498-4337-965d-94078664d03b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN96ee7ca8-3498-4337-965d-94078664d03b7
866924metoprolol tartrate 25 MG Oral TabletPSN96ee7ca8-3498-4337-965d-94078664d03b7
866514metoprolol tartrate 50 MG Oral TabletPSN96ee7ca8-3498-4337-965d-94078664d03b7
866511metoprolol tartrate 100 MG Oral TabletSCD96ee7ca8-3498-4337-965d-94078664d03b7
866924metoprolol tartrate 25 MG Oral TabletSCD96ee7ca8-3498-4337-965d-94078664d03b7
866514metoprolol tartrate 50 MG Oral TabletSCD96ee7ca8-3498-4337-965d-94078664d03b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46708-112-1046708011210100 in 1 BLISTER PACKHistorical
46708-112-304670801123030 in 1 BOTTLEHistorical
46708-112-3146708011231100 in 1 BOTTLEHistorical
46708-112-91467080112911000 in 1 BOTTLEHistorical