FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-4283
11-digit product format
500904283
Labeler code
50090
Product ID
50090-4283_80b1089d-f033-4c8a-81cf-a4e44e3309bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205253
Marketing category
ANDA
Marketing start
2017-12-11
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E8ZO8LRNM
Rxcui856373

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525eProduct name120250730
b2f15d64-48ea-ba98-af5c-91f410667b31Product name520250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4283-02023-02-07C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
50090-4283-22023-02-07C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
50090-4283-32023-02-07C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
50090-4283-02023-01-30C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
50090-4283-22023-01-30C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
50090-4283-32023-01-30C16284748780-1f386c64a-22e2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4283-0Trazodone Hydrochloride30 in 1 BOTTLETABLET3011
50090-4283-2Trazodone Hydrochloride60 in 1 BOTTLETABLET6011
50090-4283-3Trazodone Hydrochloride90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4283-0EA - Each50090-42830c318011-2a92-4c15-9fcd-966468e824a512022-04-06
50090-4283-2EA - Each50090-4283c19b3ff3-a3e8-4937-aee0-f28834c333e012022-04-06
50090-4283-3EA - Each50090-4283a22152b4-7fb1-40c5-a09d-93d00e58a95f12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4283TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20231229_353e66cc-98ca-4500-97e7-00f23f122349.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN353e66cc-98ca-4500-97e7-00f23f12234911
856373trazodone hydrochloride 100 MG Oral TabletSCD353e66cc-98ca-4500-97e7-00f23f12234911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4283-05009042830030 TABLET in 1 BOTTLE (50090-4283-0) 30 tablet2019-04-260000-00-00NoNoCurrent
50090-4283-25009042830260 TABLET in 1 BOTTLE (50090-4283-2) 60 tablet2019-04-260000-00-00NoNoCurrent
50090-4283-35009042830390 TABLET in 1 BOTTLE (50090-4283-3) 90 tablet2019-04-260000-00-00NoNoCurrent