Cyproheptadine Hydrochloride

Product NDC
10135-638
11-digit product format
101350638
Labeler code
10135
Product ID
10135-638_ec99adbb-0476-1243-e053-2a95a90a568e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA207555
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
CYPROHEPTADINE HYDROCHLORIDE
Active strength
4 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
10135-638-012024-01-30C16284748780-11030e365-0355-111a-e063-dadaa90a10e2Cyproheptadine Hydrochloride
10135-638-102024-01-30C16284748780-11030e365-0355-111a-e063-dadaa90a10e2Cyproheptadine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-638-01Cyproheptadine Hydrochloride100 in 1 BOTTLETABLET1004
10135-638-10Cyproheptadine Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-638-01EA - Each10135-638b22e0324-9f63-4429-846f-e2269c1f8ab912018-02-20
10135-638-10EA - Each10135-638c5feffbb-1da4-43e7-b822-7e97ea401f6e12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-638CYPROHEPTADINE HYDROCHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 2 package rows20221104_c382a921-f801-4b63-885a-00e71d3c19c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSNc382a921-f801-4b63-885a-00e71d3c19c74
866144cyproheptadine hydrochloride 4 MG Oral TabletSCDc382a921-f801-4b63-885a-00e71d3c19c74
866144cyproheptadine HCl 4 MG Oral TabletPSN42aa7300-0889-4f46-98fa-0f5d9546709b1
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD42aa7300-0889-4f46-98fa-0f5d9546709b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-638-0110135063801100 TABLET in 1 BOTTLE (10135-638-01) 100 tablet2018-01-010000-00-00NoNoCurrent
10135-638-10101350638101000 TABLET in 1 BOTTLE (10135-638-10) 1000 tablet2018-01-010000-00-00NoNoCurrent