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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

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Paregoric - FDA Drug Approval Details