FDA.reportPublic FDA data

CYPROHEPTADINE HYDROCHLORIDE

Product NDC
72162-2065
11-digit product format
721622065
Labeler code
72162
Product ID
72162-2065_34667b54-e4af-3fe6-e063-6294a90af0e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYPROHEPTADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212423
Marketing category
ANDA
Marketing start
2019-05-22
Substance
CYPROHEPTADINE HYDROCHLORIDE
Active strength
2 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYPROHEPTADINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYPROHEPTADINE HYDROCHLORIDE2 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNJ82J0F8QC
Rxcui866021

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
72162-2065-2CYPROHEPTADINE HYDROCHLORIDE473 mL in 1 BOTTLE, GLASSSOLUTION473105
72162-2065-4CYPROHEPTADINE HYDROCHLORIDE473 mL in 1 BOTTLE, GLASSSOLUTION473105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2065-2ML - Milliliter72162-2065711e9c4d-7a9d-481a-933c-5be2da5c500512023-09-05
72162-2065-4ML - Milliliter72162-2065ed0f26dc-2eee-4c90-aa67-9bce238e207c12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2065CYPROHEPTADINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]105Current NDC, 2 package rows20250507_996dd4c6-ebcf-42e8-a950-9d34bb6f404f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSN996dd4c6-ebcf-42e8-a950-9d34bb6f404f105
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCD996dd4c6-ebcf-42e8-a950-9d34bb6f404f105
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSY996dd4c6-ebcf-42e8-a950-9d34bb6f404f105
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSY996dd4c6-ebcf-42e8-a950-9d34bb6f404f105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2065-272162206502473 mL in 1 BOTTLE, GLASS (72162-2065-2) 473 ml2024-08-12NoNoHistorical
72162-2065-472162206504473 mL in 1 BOTTLE, GLASS (72162-2065-4) 473 ml2025-05-02NoNoHistorical