CYPROHEPTADINE HYDROCHLORIDE

Product NDC
64380-795
11-digit product format
643800795
Labeler code
64380
Product ID
64380-795_54787424-10c7-40b3-b1ca-5a796572ad34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYPROHEPTADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA209172
Marketing category
ANDA
Marketing start
2018-04-11
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
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
64380-795-06CYPROHEPTADINE HYDROCHLORIDE100 in 1 BOTTLETABLET1002
64380-795-08CYPROHEPTADINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-795-06EA - Each64380-795ebc3786c-1f74-4b6b-9edc-855ad4676bb412018-09-05
64380-795-08EA - Each64380-79519ce3ddb-b708-4e7b-be7c-356355edb76412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-795CYPROHEPTADINE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]2Current NDC, Legacy NDC, 2 package rows20221123_b28c2ca0-140d-44d8-a59e-75fbfe8eabdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSNab58d4df-69d4-43ac-ac6c-871fcc6c946d3
866144cyproheptadine hydrochloride 4 MG Oral TabletSCDab58d4df-69d4-43ac-ac6c-871fcc6c946d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-795-0664380079506100 TABLET in 1 BOTTLE (64380-795-06) 100 tablet2018-04-110000-00-00NoNoCurrent
64380-795-08643800795081000 TABLET in 1 BOTTLE (64380-795-08) 1000 tablet2018-04-110000-00-00NoNoCurrent