FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
42254-005
11-digit product format
422540005
Labeler code
42254
Product ID
42254-005_34f4cc6f-3751-470a-95c1-69ea911e24f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA078955
Marketing category
ANDA
Marketing start
2008-10-13
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [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
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-005-302019-09-24C16284748780-19350213a-3c05-c013-e053-90daa90a1393Propranolol Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-005-30Propranolol Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-005-30EA - Each42254-00564c993fd-9af6-4fd5-8092-3bb67dbfc5c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-005PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20111118_34f4cc6f-3751-470a-95c1-69ea911e24f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856556propranolol HCl 60 MG Oral TabletPSN34f4cc6f-3751-470a-95c1-69ea911e24f51
856556propranolol hydrochloride 60 MG Oral TabletSCD34f4cc6f-3751-470a-95c1-69ea911e24f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-005-304225400053030 in 1 BOTTLEHistorical