FDA.reportPublic FDA data

Nefazodone Hydrochloride

Product NDC
21695-175
11-digit product format
216950175
Labeler code
21695
Product ID
21695-175_4afee435-ae60-4260-a1df-e52abf7a043d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nefazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076037
Marketing category
ANDA
Marketing start
2003-09-16
Marketing end
0000-00-00
Substance
NEFAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [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
88e577a5-ea68-76d2-a3c4-7157b94bcfa5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-175-602019-09-24C16284748780-1934fe258-4ab2-48b1-e053-8cdaa90a720aNEFAZODONE HYDROCHLORIDE TABLETS 7178 1024 7113 1025 1026 (Patient Information Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-175-60Nefazodone Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-175-60EA - Each21695-175d8724dc7-97c2-44e6-9321-19f278d5a0ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nefazodone hydrochlorideACTIVE INGREDIENT27X63J94GRNEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
nefazodoneACTIVE MOIETY59H4FCV1TFNEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-175NEFAZODONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110622_4afee435-ae60-4260-a1df-e52abf7a043d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098649nefazodone HCl 100 MG Oral TabletPSN4afee435-ae60-4260-a1df-e52abf7a043d1
1098666nefazodone HCl 150 MG Oral TabletPSN4afee435-ae60-4260-a1df-e52abf7a043d1
1098670nefazodone HCl 200 MG Oral TabletPSN4afee435-ae60-4260-a1df-e52abf7a043d1
1098674nefazodone HCl 250 MG Oral TabletPSN4afee435-ae60-4260-a1df-e52abf7a043d1
1098649nefazodone hydrochloride 100 MG Oral TabletSCD4afee435-ae60-4260-a1df-e52abf7a043d1
1098666nefazodone hydrochloride 150 MG Oral TabletSCD4afee435-ae60-4260-a1df-e52abf7a043d1
1098670nefazodone hydrochloride 200 MG Oral TabletSCD4afee435-ae60-4260-a1df-e52abf7a043d1
1098674nefazodone hydrochloride 250 MG Oral TabletSCD4afee435-ae60-4260-a1df-e52abf7a043d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-175-602169501756060 in 1 BOTTLEHistorical