FDA.reportPublic FDA data

RAZADYNE

Product NDC
50458-398
11-digit product format
504580398
Labeler code
50458
Product ID
50458-398_ab2b6dfa-8107-11eb-8513-17f1fb2ca371
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
galantamine hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA021169
Marketing category
NDA
Marketing start
2001-03-01
Marketing end
2022-03-04
Substance
GALANTAMINE HYDROBROMIDE
Active strength
12 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f780b87f-43f1-2d63-f0ea-2c214058238eProduct name220160831

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-398-60EA - Each50458-3982ff0a454-1f7d-4a0b-94ec-422682a640bd12012-07-24

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 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