Acetylcysteine

Product NDC: 17478-660
11-digit product format: 174780660
Labeler code: 17478
Product ID: 17478-660_0c987ea3-3834-4c1c-94a8-81270ad88f99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetylcysteine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Akorn
Application: ANDA203173
Marketing category: ANDA
Marketing start: 2015-03-25
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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7b19f89e-0a13-4d4e-a994-a46d39d008b9	Product name	1	20251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2	Product name	8	20221116
f46c867f-cde5-4f14-a7c1-18ae3a6efd1c	Product name	1	20160303

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-660-30	2024-01-30	C162847	48780-1	1030e365-5e9c-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ACETYLCYSTEINE INJECTION safely and effectively. See full prescribing information for ACETYLCYSTEINE INJECTION. ACETYLCYSTEINE injection, for intravenous use Initial U.S. Approval: 2004

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-660-30	Acetylcysteine	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION	30		9
17478-660-30	Acetylcysteine	4 in 1 CARTON	INJECTION	4		9

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-660-30	ML - Milliliter	17478-660	01622c52-10a3-4024-a1b6-96ee13e0ce91	1	2015-07-20

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetylcysteine	ACTIVE INGREDIENT	WYQ7N0BPYC	ACETYLCYSTEINE INJECTION [AKORN, INC.]	3
Acetylcysteine	ACTIVE MOIETY	WYQ7N0BPYC	ACETYLCYSTEINE INJECTION [AKORN, INC.]	3
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	ACETYLCYSTEINE INJECTION [AKORN, INC.]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ACETYLCYSTEINE INJECTION [AKORN, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	ACETYLCYSTEINE INJECTION [AKORN, INC.]	3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-660	ACETYLCYSTEINE INJECTION [AKORN]	9	Legacy NDC, 2 package rows	20220622_4072b547-c242-4a40-8c91-5481b86cbf1e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WYQ7N0BPYC	ACETYLCYSTEINE	616-91-1	ACETYLCYSTEINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
465377	acetylcysteine 6 GM in 30 ML Injection	PSN	4072b547-c242-4a40-8c91-5481b86cbf1e	9
465377	30 ML acetylcysteine 200 MG/ML Injection	SCD	4072b547-c242-4a40-8c91-5481b86cbf1e	9
465377	acetylcysteine 6 GM per 30 ML Injection	SY	4072b547-c242-4a40-8c91-5481b86cbf1e	9

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-660-30	17478066030	4 VIAL, SINGLE-DOSE in 1 CARTON (17478-660-30) > 30 mL in 1 VIAL, SINGLE-DOSE	2015-03-25	0000-00-00	No	No	Current