cyproheptadine hydrochloride solution

Product NDC
58657-697
11-digit product format
586570697
Labeler code
58657
Product ID
58657-697_41b48ab2-962e-790a-e063-6394a90a6106
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYPROHEPTADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA209108
Marketing category
ANDA
Marketing start
2024-06-15
Substance
CYPROHEPTADINE
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 solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYPROHEPTADINE2 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2YHB6175DO
Rxcui866021

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-697-16cyproheptadine hydrochloride solution473 mL in 1 BOTTLE, GLASSSOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-697-16ML - Milliliter58657-697ebafd83f-b940-422b-b58b-e4011ab3e5a512024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-697CYPROHEPTADINE HYDROCHLORIDE SOLUTION (CYPROHEPTADINE HYDROCHLORIDE) SOLUTION [METHOD PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20240817_1acfd050-6c07-a269-e063-6394a90a77e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSN1acfd050-6c07-a269-e063-6394a90a77e82
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCD1acfd050-6c07-a269-e063-6394a90a77e82
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSY1acfd050-6c07-a269-e063-6394a90a77e82
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSY1acfd050-6c07-a269-e063-6394a90a77e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-697-1658657069716473 mL in 1 BOTTLE, GLASS (58657-697-16) 473 ml2024-06-15NoNoCurrent