FDA.reportPublic FDA data

Cyproheptadine Hydrochloride

Product NDC
64980-504
11-digit product format
649800504
Labeler code
64980
Product ID
64980-504_9b4845c1-9b59-4809-9247-50565fc4b6fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA040668
Marketing category
ANDA
Marketing start
2006-07-10
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-504-48Cyproheptadine Hydrochloride473 mL in 1 BOTTLESYRUP4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-504-48ML - Milliliter64980-50412035111-1990-4687-b8be-42eff4f6f72512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYPROHEPTADINE HYDROCHLORIDEACTIVE INGREDIENTNJ82J0F8QCCYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4
CYPROHEPTADINEACTIVE MOIETY2YHB6175DOCYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MCYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BCYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RCYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-504CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20250402_e2bf4d46-6585-41d9-868c-98603b165d5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSNe2bf4d46-6585-41d9-868c-98603b165d5b9
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCDe2bf4d46-6585-41d9-868c-98603b165d5b9
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSYe2bf4d46-6585-41d9-868c-98603b165d5b9
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSYe2bf4d46-6585-41d9-868c-98603b165d5b9
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSN949743a7-f922-4248-aa28-818236c80a672
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCD949743a7-f922-4248-aa28-818236c80a672
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSY949743a7-f922-4248-aa28-818236c80a672
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSY949743a7-f922-4248-aa28-818236c80a672
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSN50b3abc0-d86a-e8f5-e063-6394a90ad25e1
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCD50b3abc0-d86a-e8f5-e063-6394a90ad25e1
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSY50b3abc0-d86a-e8f5-e063-6394a90ad25e1
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSY50b3abc0-d86a-e8f5-e063-6394a90ad25e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-504-4864980050448473 mL in 1 BOTTLE (64980-504-48) 473 ml2006-07-100000-00-00NoNoCurrent