FDA.reportPublic FDA data

Cyproheptadine Hydrochloride

Product NDC
52817-210
11-digit product format
528170210
Labeler code
52817
Product ID
52817-210_c67264ab-9491-4aee-a28a-c97e1497915b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TRUPHARMA, LLC
Application
ANDA206553
Marketing category
ANDA
Marketing start
2017-01-17
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
52817-210-10Cyproheptadine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1005
52817-210-50Cyproheptadine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-210-10EA - Each52817-210c4ce3ec1-7ade-44e7-a337-642f17e240ce12017-03-06
52817-210-50EA - Each52817-2104d424453-884b-41d3-be45-5bb7902ce44512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-210CYPROHEPTADINE HYDROCHLORIDE TABLET [TRUPHARMA, LLC]5Current NDC, Legacy NDC, 2 package rows20220826_9c0b47c0-ecd2-450f-9dcb-c262db92866e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSN9c0b47c0-ecd2-450f-9dcb-c262db92866e5
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD9c0b47c0-ecd2-450f-9dcb-c262db92866e5
866144cyproheptadine HCl 4 MG Oral TabletPSN7e156e5e-e4cc-420b-8f1a-af123eaa91564
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD7e156e5e-e4cc-420b-8f1a-af123eaa91564
866144cyproheptadine HCl 4 MG Oral TabletPSNfc75bd79-63b7-6388-e053-6394a90ac3773
866144cyproheptadine hydrochloride 4 MG Oral TabletSCDfc75bd79-63b7-6388-e053-6394a90ac3773

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-210-1052817021010100 TABLET in 1 BOTTLE, PLASTIC (52817-210-10) 100 tablet2017-01-170000-00-00NoNoCurrent
52817-210-5052817021050500 TABLET in 1 BOTTLE, PLASTIC (52817-210-50) 500 tablet2017-01-170000-00-00NoNoCurrent