cyproheptadine hydrochloride

Generic: cyproheptadine hydrochloride

Labeler: tris pharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyproheptadine hydrochloride
Generic Name cyproheptadine hydrochloride
Labeler tris pharma inc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

cyproheptadine hydrochloride 2 mg/5mL

Manufacturer
Tris Pharma Inc

Identifiers & Regulatory

Product NDC 27808-099
Product ID 27808-099_33793609-a343-4194-8417-247b70b514de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205431
Listing Expiration 2026-12-31
Marketing Start 2021-12-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808099
Hyphenated Format 27808-099

Supplemental Identifiers

RxCUI
866021
UPC
0327808099013
UNII
NJ82J0F8QC

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cyproheptadine hydrochloride (source: ndc)
Generic Name cyproheptadine hydrochloride (source: ndc)
Application Number ANDA205431 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (27808-099-01)
source: ndc

Packages (1)

27808-099-01 473 mL in 1 BOTTLE, PLASTIC (27808-099-01)

Ingredients (1)

cyproheptadine hydrochloride (2 mg/5mL)

Linked Drug Pages (1)

Cyproheptadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "33793609-a343-4194-8417-247b70b514de", "openfda": {"upc": ["0327808099013"], "unii": ["NJ82J0F8QC"], "rxcui": ["866021"], "spl_set_id": ["2b438746-14c2-44ef-a127-62b8d2efdc55"], "manufacturer_name": ["Tris Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (27808-099-01)", "package_ndc": "27808-099-01", "marketing_start_date": "20221230"}], "brand_name": "Cyproheptadine Hydrochloride", "product_id": "27808-099_33793609-a343-4194-8417-247b70b514de", "dosage_form": "SYRUP", "product_ndc": "27808-099", "generic_name": "Cyproheptadine Hydrochloride", "labeler_name": "Tris Pharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyproheptadine Hydrochloride", "active_ingredients": [{"name": "CYPROHEPTADINE HYDROCHLORIDE", "strength": "2 mg/5mL"}], "application_number": "ANDA205431", "marketing_category": "ANDA", "marketing_start_date": "20211221", "listing_expiration_date": "20261231"}