CYPROHEPTADINE HYDROCHLORIDE

Product NDC
70752-101
11-digit product format
707520101
Labeler code
70752
Product ID
70752-101_4cf663f3-74cb-4b2c-b909-e6495d2ead78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYPROHEPTADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-101-12CYPROHEPTADINE HYDROCHLORIDE473 mL in 1 BOTTLE, GLASSSOLUTION47311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-101-12ML - Milliliter70752-1016a16bb4c-fe18-4132-9ebb-449089ec52df12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-101CYPROHEPTADINE HYDROCHLORIDE SOLUTION [QUAGEN PHARMACEUTICALS LLC]11Current NDC, Legacy NDC, 1 package rows20240616_d3ce21de-849a-47ab-8405-968d8de6f1e9.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
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSNd3ce21de-849a-47ab-8405-968d8de6f1e911
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCDd3ce21de-849a-47ab-8405-968d8de6f1e911
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSYd3ce21de-849a-47ab-8405-968d8de6f1e911
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSYd3ce21de-849a-47ab-8405-968d8de6f1e911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-101-1270752010112473 mL in 1 BOTTLE, GLASS (70752-101-12) 473 ml2019-05-220000-00-00NoNoCurrent