Cyproheptadine Hydrochloride

Product NDC
0115-1757
11-digit product format
001151757
Labeler code
0115
Product ID
0115-1757_a6cccfd7-dc3b-4191-9319-25a5a6c759f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040537
Marketing category
ANDA
Marketing start
2015-07-29
Substance
CYPROHEPTADINE HYDROCHLORIDE
Active strength
4 mg/1
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 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
0115-1757-01Cyproheptadine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1009
0115-1757-03Cyproheptadine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1757-01EA - Each0115-175767d60974-9a78-4848-b373-9ac409f2a7a312018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1757CYPROHEPTADINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]9Current NDC, Legacy NDC, 2 package rows20250108_80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSN6a5b5a89-82c2-4991-b026-d160d8fa59a3100
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD6a5b5a89-82c2-4991-b026-d160d8fa59a3100
866144cyproheptadine HCl 4 MG Oral TabletPSN80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e9
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e9
866144cyproheptadine HCl 4 MG Oral TabletPSN426acecc-aef4-099c-e063-6294a90a54eb1
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD426acecc-aef4-099c-e063-6294a90a54eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1757-0100115175701100 TABLET in 1 BOTTLE, PLASTIC (0115-1757-01) 100 tablet2015-07-290000-00-00NoNoCurrent
0115-1757-03001151757031000 TABLET in 1 BOTTLE, PLASTIC (0115-1757-03) 1000 tablet2015-07-290000-00-00NoNoCurrent