ACETYLCYSTEINE

Product NDC
72611-860
11-digit product format
726110860
Labeler code
72611
Product ID
72611-860_c32fe773-7b1e-a499-c4ca-c6cee49da0c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETYLCYSTEINE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Almaject, Inc.
Application
ANDA215620
Marketing category
ANDA
Marketing start
2022-10-17
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72611-860-01ML - Milliliter72611-8600c14ddfc-9f1a-4bcc-85ac-133187f6a04312022-11-07
72611-860-04ML - Milliliter72611-8608b814ce7-76b8-415c-bc89-a483df12682a12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72611-860ACETYLCYSTEINE INJECTION [ALMAJECT, INC.]4Legacy NDC20250117_0298bda7-0edf-99c7-8266-ab45bb5c6e16.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72611-860-04726110860044 VIAL, SINGLE-DOSE in 1 CARTON (72611-860-04) > 30 mL in 1 VIAL, SINGLE-DOSE (72611-860-01) 2022-10-240000-00-00NoNoCurrent