Cyproheptadine Hydrochloride

Product NDC
27808-099
11-digit product format
278080099
Labeler code
27808
Product ID
27808-099_33793609-a343-4194-8417-247b70b514de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Tris Pharma Inc
Application
ANDA205431
Marketing category
ANDA
Marketing start
2021-12-21
Substance
CYPROHEPTADINE HYDROCHLORIDE
Active strength
2 mg/5mL
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 HYDROCHLORIDE2 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNJ82J0F8QC
Rxcui866021

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
9917ef47-291c-0597-9549-0221b002efcdProduct name720210804
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
67b21aa0-8a78-94d2-63ec-d7e6aa48ff6bProduct name520190821
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-099-01Cyproheptadine Hydrochloride473 mL in 1 BOTTLE, PLASTICSYRUP4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-099CYPROHEPTADINE HYDROCHLORIDE SYRUP [TRIS PHARMA INC]2Current NDC, Legacy NDC, 1 package rows20220316_2b438746-14c2-44ef-a127-62b8d2efdc55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSN2b438746-14c2-44ef-a127-62b8d2efdc552
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCD2b438746-14c2-44ef-a127-62b8d2efdc552
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSY2b438746-14c2-44ef-a127-62b8d2efdc552
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSY2b438746-14c2-44ef-a127-62b8d2efdc552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-099-0127808009901473 mL in 1 BOTTLE, PLASTIC (27808-099-01) 473 ml2022-12-300000-00-00NoNoCurrent