Methyldopa

Product NDC
42254-351
11-digit product format
422540351
Labeler code
42254
Product ID
42254-351_fa1c61c2-7e24-40ff-916e-456b8725a5cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methyldopa
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA070098
Marketing category
ANDA
Marketing start
2009-02-23
Marketing end
0000-00-00
Substance
METHYLDOPA
Active strength
250 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
512b4ef2-bf6c-5103-2bac-fd8ec25453adProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-351-902019-09-24C16284748780-19350213a-3daf-c013-e053-90daa90a1393METHYLDOPA TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-351-90Methyldopa90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-351-90EA - Each42254-3510e133aa5-a2aa-4b6f-a184-9efd48df231512013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLDOPAACTIVE INGREDIENT56LH93261YMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
METHYLDOPA ANHYDROUSACTIVE MOIETYM4R0H12F6MMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505METHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-351METHYLDOPA TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130228_fa1c61c2-7e24-40ff-916e-456b8725a5cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197956methyldopa 250 MG Oral TabletPSNfa1c61c2-7e24-40ff-916e-456b8725a5cd1
197956methyldopa 250 MG Oral TabletSCDfa1c61c2-7e24-40ff-916e-456b8725a5cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-351-904225403519090 in 1 BOTTLEHistorical