Paregoric
Paregoric, USP
Approved
Approval ID
405b7997-1e47-4904-96d0-72c241ed8195
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2018
Manufacturers
FDA
Hi-Tech Pharmacal Co., Inc.
DUNS: 101196749
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paregoric
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-855
Product Classification
G
Generic Name
Paregoric
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2016
FDA Product Classification
INGREDIENTS (7)
MORPHINEActive
Quantity: 2 mg in 5 mL
Code: 76I7G6D29C
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANISE OILInactive
Code: 6Y89129C8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CAMPHOR OILInactive
Code: 75IZZ8Y727
Classification: IACT