FDA.reportPublic FDA data

Cyproheptadine Hydrochloride

Product NDC
50090-5491
11-digit product format
500905491
Labeler code
50090
Product ID
50090-5491_28b91c2a-e33a-4b09-8636-4c53ea6f1358
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5491-02023-02-07C16284748780-1f386c64a-49bb-0266-e053-dadaa90a7c1aCYPROHEPTADINE HYDROCHLORIDE TABLETS USP
50090-5491-12023-02-07C16284748780-1f386c64a-49bb-0266-e053-dadaa90a7c1aCYPROHEPTADINE HYDROCHLORIDE TABLETS USP
50090-5491-02023-01-30C16284748780-1f386c64a-49bb-0266-e053-dadaa90a7c1aCYPROHEPTADINE HYDROCHLORIDE TABLETS USP
50090-5491-12023-01-30C16284748780-1f386c64a-49bb-0266-e053-dadaa90a7c1aCYPROHEPTADINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5491-0Cyproheptadine Hydrochloride100 in 1 BOTTLETABLET1004
50090-5491-1Cyproheptadine Hydrochloride30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5491-1EA - Each50090-5491dcdc515e-deb0-48bf-b4b8-189216fce10212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5491CYPROHEPTADINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20230919_7e156e5e-e4cc-420b-8f1a-af123eaa9156.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSN7e156e5e-e4cc-420b-8f1a-af123eaa91564
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD7e156e5e-e4cc-420b-8f1a-af123eaa91564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5491-050090549100100 TABLET in 1 BOTTLE (50090-5491-0) 100 tablet2021-03-160000-00-00NoNoCurrent
50090-5491-15009054910130 TABLET in 1 BOTTLE (50090-5491-1) 30 tablet2021-03-160000-00-00NoNoCurrent