CYPROHEPTADINE HYDROCHLORIDE

Product NDC
70518-3517
11-digit product format
705183517
Labeler code
70518
Product ID
70518-3517_4f1ffe50-29f4-fe99-e063-6294a90a2ceb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYPROHEPTADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212491
Marketing category
ANDA
Marketing start
2022-09-13
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
70518-3517-0CYPROHEPTADINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3517CYPROHEPTADINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 1 package rows20240322_7b3aed50-cc9e-4897-9735-361225e9e5f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSN7b3aed50-cc9e-4897-9735-361225e9e5f25
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD7b3aed50-cc9e-4897-9735-361225e9e5f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3517-07051835170030 TABLET in 1 BLISTER PACK (70518-3517-0) 30 tablet2022-09-130000-00-00NoNoCurrent