Nefazodone Hydrochloride

Product NDC
63629-7046
11-digit product format
636297046
Labeler code
63629
Product ID
63629-7046_8962e4a7-1e27-4a03-ab51-34fc4f9c6847
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nefazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076037
Marketing category
ANDA
Marketing start
2003-09-16
Substance
NEFAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nefazodone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEFAZODONE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27X63J94GR
Rxcui1098666

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
63629-7046-12025-09-04C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22025-09-04C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32025-09-04C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42025-09-04C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12024-01-30C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22024-01-30C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32024-01-30C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42024-01-30C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12020-02-25C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22020-02-25C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32020-02-25C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42020-02-25C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-12020-01-31C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-22020-01-31C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-32020-01-31C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
63629-7046-42020-01-31C16284748780-19d75b9cf-e681-f424-e053-dadaa90a57ceNefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7046-1Nefazodone Hydrochloride30 in 1 BOTTLETABLET3019
63629-7046-2Nefazodone Hydrochloride120 in 1 BOTTLETABLET12019
63629-7046-3Nefazodone Hydrochloride28 in 1 BOTTLETABLET2819
63629-7046-4Nefazodone Hydrochloride60 in 1 BOTTLETABLET6019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7046NEFAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 4 package rows20220217_0bd4c34a-4f43-4c84-8b98-1d074cba97d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098666nefazodone HCl 150 MG Oral TabletPSN0bd4c34a-4f43-4c84-8b98-1d074cba97d519
1098666nefazodone hydrochloride 150 MG Oral TabletSCD0bd4c34a-4f43-4c84-8b98-1d074cba97d519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7046-16362970460130 TABLET in 1 BOTTLE (63629-7046-1) 30 tablet2022-02-080000-00-00NoNoCurrent
63629-7046-263629704602120 TABLET in 1 BOTTLE (63629-7046-2) 120 tablet2016-10-180000-00-00NoNoCurrent
63629-7046-36362970460328 TABLET in 1 BOTTLE (63629-7046-3) 28 tablet2022-02-080000-00-00NoNoCurrent
63629-7046-46362970460460 TABLET in 1 BOTTLE (63629-7046-4) 60 tablet2022-02-080000-00-00NoNoCurrent