FDA.reportPublic FDA data

Cyproheptadine Hydrochloride

Product NDC
76385-130
11-digit product format
763850130
Labeler code
76385
Product ID
76385-130_d68a0f7b-98e1-4d8c-a236-9d701e4e68d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
UNICHEM PHARMACEUTICALS (USA), INC.
Application
ANDA206676
Marketing category
ANDA
Marketing start
2020-03-01
Substance
CYPROHEPTADINE HYDROCHLORIDE
Active strength
4 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYPROHEPTADINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNJ82J0F8QC
Rxcui866144

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9917ef47-291c-0597-9549-0221b002efcdProduct name720210804
67b21aa0-8a78-94d2-63ec-d7e6aa48ff6bProduct name520190821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76385-130-01Cyproheptadine Hydrochloride100 in 1 BOTTLETABLET1006
76385-130-10Cyproheptadine Hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-130-01EA - Each76385-130711f853b-4c59-4188-9b30-c106b56e561b12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-130CYPROHEPTADINE HYDROCHLORIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 2 package rows20240118_99fb821a-fe33-4468-9026-9729a8deff08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSN03e69414-8a25-4ed8-b7ac-16445b879b1f13
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD03e69414-8a25-4ed8-b7ac-16445b879b1f13
866144cyproheptadine HCl 4 MG Oral TabletPSN99fb821a-fe33-4468-9026-9729a8deff086
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD99fb821a-fe33-4468-9026-9729a8deff086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76385-130-0176385013001100 TABLET in 1 BOTTLE (76385-130-01) 100 tablet2020-03-010000-00-00NoNoCurrent
76385-130-10763850130101000 TABLET in 1 BOTTLE (76385-130-10) 1000 tablet2020-03-010000-00-00NoNoCurrent