ACETADOTE

Product NDC: 66220-207
11-digit product format: 662200207
Labeler code: 66220
Product ID: 66220-207_f8e9f360-c181-40a1-87d6-dcd9a3205000
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetylcysteine
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Cumberland Pharmaceuticals Inc.
Application: NDA021539
Marketing category: NDA
Marketing start: 2004-01-23
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ACETYLCYSTEINE	200 mg/mL

Field, Values table
Field	Values
Unii	WYQ7N0BPYC
Rxcui	465377, 582119

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
66220-207-30	2023-01-27	C162847	48780-1	e4f33bdf-b22f-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ACETADOTE safely and effectively. See full prescribing information for ACETADOTE. ACETADOTE (acetylcysteine) injection, for intravenous use Initial U.S. Approval: 2004
66220-207-30	2022-07-29	C162847	48780-1	e4f33bdf-b22f-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ACETADOTE safely and effectively. See full prescribing information for ACETADOTE. ACETADOTE (acetylcysteine) injection, for intravenous use Initial U.S. Approval: 2004

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66220-207-30	ACETADOTE	30 mL in 1 VIAL	INJECTION, SOLUTION	30		17
66220-207-30	ACETADOTE	4 in 1 CARTON	INJECTION, SOLUTION	4		17

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66220-207-30	ML - Milliliter	66220-207	af63f276-3b51-41cf-9775-31eaa4b563f1	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetylcysteine	ACTIVE INGREDIENT	WYQ7N0BPYC	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5
Acetylcysteine	ACTIVE MOIETY	WYQ7N0BPYC	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5
nitrogen	INACTIVE INGREDIENT	N762921K75	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66220-207	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 2 package rows	20241207_472f158a-5ab9-4308-8e49-1116e6ea3d39.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
582119	Acetadote 6 GM in 30 ML Injection	PSN	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
465377	acetylcysteine 6 GM in 30 ML Injection	PSN	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
582119	30 ML acetylcysteine 200 MG/ML Injection [Acetadote]	SBD	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
465377	30 ML acetylcysteine 200 MG/ML Injection	SCD	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
582119	Acetadote 6 GM per 30 ML Injection	SY	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
465377	acetylcysteine 6 GM per 30 ML Injection	SY	472f158a-5ab9-4308-8e49-1116e6ea3d39	17

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66220-207-30	66220020730	4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL	4 vial	2004-01-23	0000-00-00	No	No	Current