Acetylcysteine

Product NDC

0574-0815

11-digit product format

005740815

Labeler code

0574

Product ID

0574-0815_1cc266a0-3499-42da-93b3-a3ed19687f4e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

acetylcysteine

Dosage form

INJECTION

Route

INTRAVENOUS

Labeler

Paddock Laboratories, LLC

Application

NDA021539

Marketing category

NDA

Marketing start

2013-10-15

Marketing end

2021-02-01

Substance

ACETYLCYSTEINE

Active strength

200 mg/mL

Pharmacologic classes

Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record