Cyproheptadine Hydrochloride

Product NDC
39328-544
11-digit product format
393280544
Labeler code
39328
Product ID
39328-544_fcdc36f7-1523-46dc-a976-c3d150fae843
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Patrin Pharma, Inc.
Application
ANDA209108
Marketing category
ANDA
Marketing start
2022-02-15
Substance
CYPROHEPTADINE
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
CYPROHEPTADINE2 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2YHB6175DO
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
39328-544-16Cyproheptadine Hydrochloride473 mL in 1 BOTTLE, GLASSSOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-544-16ML - Milliliter39328-544bd861bff-c99e-40a6-aad6-c628c016f49a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-544CYPROHEPTADINE HYDROCHLORIDE SOLUTION [PATRIN PHARMA, INC.]1Current NDC, Legacy NDC, 1 package rows20220302_81d9523f-f945-4410-8b71-8b5fea48a3da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSN81d9523f-f945-4410-8b71-8b5fea48a3da1
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCD81d9523f-f945-4410-8b71-8b5fea48a3da1
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSY81d9523f-f945-4410-8b71-8b5fea48a3da1
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSY81d9523f-f945-4410-8b71-8b5fea48a3da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39328-544-1639328054416473 mL in 1 BOTTLE, GLASS (39328-544-16) 473 ml2022-02-150000-00-00NoNoCurrent