Cyproheptadine Hydrochloride

Product NDC
16571-805
11-digit product format
165710805
Labeler code
16571
Product ID
16571-805_93f4f73b-1ff4-4a64-a8ec-4a574abc3dd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA207555
Marketing category
ANDA
Marketing start
2022-02-09
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
16571-805-01Cyproheptadine Hydrochloride100 in 1 BOTTLETABLET1001
16571-805-10Cyproheptadine Hydrochloride1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-805-01EA - Each16571-805d1f7f490-b670-4f5d-91e0-889e71d5691e12022-03-09
16571-805-10EA - Each16571-805b53c9dd5-b136-4c23-94b8-c083f63f900312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-805CYPROHEPTADINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, Legacy NDC, 2 package rows20220210_c5e9e983-d0d2-4f87-beae-0d853ca43983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSNc5e9e983-d0d2-4f87-beae-0d853ca439831
866144cyproheptadine hydrochloride 4 MG Oral TabletSCDc5e9e983-d0d2-4f87-beae-0d853ca439831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-805-0116571080501100 TABLET in 1 BOTTLE (16571-805-01) 100 tablet2022-02-100000-00-00NoNoCurrent
16571-805-10165710805101000 TABLET in 1 BOTTLE (16571-805-10) 1000 tablet2022-02-100000-00-00NoNoCurrent