FDA.reportPublic FDA data

Cyproheptadine Hydrochloride

Product NDC
72789-102
11-digit product format
727890102
Labeler code
72789
Product ID
72789-102_4af611bc-838d-98d2-e063-6294a90a74d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA206676
Marketing category
ANDA
Marketing start
2020-03-01
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
72789-102-01Cyproheptadine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10013
72789-102-30Cyproheptadine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-102-01EA - Each72789-1027d218423-1a97-45bc-9177-f0d789edfcc812020-09-14
72789-102-30EA - Each72789-10262a7805f-e1c3-47e8-bec1-623163486b8012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-102CYPROHEPTADINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 2 package rows20250121_03e69414-8a25-4ed8-b7ac-16445b879b1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSN03e69414-8a25-4ed8-b7ac-16445b879b1f13
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD03e69414-8a25-4ed8-b7ac-16445b879b1f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-102-0172789010201100 TABLET in 1 BOTTLE, PLASTIC (72789-102-01) 100 tablet2023-07-100000-00-00NoNoCurrent
72789-102-307278901023030 TABLET in 1 BOTTLE, PLASTIC (72789-102-30) 30 tablet2020-07-27NoNoCurrent