RAZADYNE

Product NDC
21695-591
11-digit product format
216950591
Labeler code
21695
Product ID
21695-591_ea6968e3-6383-4ff1-8c81-e4a2fdfe749d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
galantamine hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021169
Marketing category
NDA
Marketing start
2001-02-28
Marketing end
0000-00-00
Substance
GALANTAMINE HYDROBROMIDE
Active strength
12 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
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
f780b87f-43f1-2d63-f0ea-2c214058238eProduct name220160831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-591-302019-09-24C16284748780-1934fe258-493e-48b1-e053-8cdaa90a720aRAZADYNE ® galantamine HBr TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-591-30RAZADYNE30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-591-30EA - Each21695-591953ee43a-9bca-4de7-a6db-57f9ea05a42912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
galantamine hydrobromideACTIVE INGREDIENTMJ4PTD2VVWRAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
galantamineACTIVE MOIETY0D3Q044KCARAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XRAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
magnesium stearateINACTIVE INGREDIENT70097M6I30RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
talcINACTIVE INGREDIENT7SEV7J4R1URAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-591RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2Legacy NDC, 1 package rows20110224_e62efb5a-d2cc-4e11-9e61-10e65ef3d897.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
579148galantamine HBr 12 MG Oral TabletPSNe62efb5a-d2cc-4e11-9e61-10e65ef3d8972
602734Razadyne 12 MG Oral TabletPSNe62efb5a-d2cc-4e11-9e61-10e65ef3d8972
602734galantamine 12 MG Oral Tablet [Razadyne]SBDe62efb5a-d2cc-4e11-9e61-10e65ef3d8972
579148galantamine 12 MG Oral TabletSCDe62efb5a-d2cc-4e11-9e61-10e65ef3d8972
579148galantamine 12 MG (as galantamine hydrobromide 15.379 MG) Oral TabletSYe62efb5a-d2cc-4e11-9e61-10e65ef3d8972
602734Razadyne 12 MG (galantamine hydrobromide 15.379 MG) Oral TabletSYe62efb5a-d2cc-4e11-9e61-10e65ef3d8972
602734Razadyne 12 MG Oral TabletSYe62efb5a-d2cc-4e11-9e61-10e65ef3d8972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-591-302169505913030 in 1 BOTTLEHistorical