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ACETYLCYSTEINE injection


  1. Principal Display Panel Text For Container Label:
  2. Principal Display Panel Text For Carton Label:
  3. Revised: 11/2017document Id:
  4. Patient Information

Principal Display Panel Text For Container Label: 

NDC 17478-660-30

Acetylcysteine

Injection

6 g/30 mL

(200 mg/mL)

Must be Further Diluted Prior to

Intravenous Use

30 mL Single dose Vial

Principal Display Panel Text for Container Label

Principal Display Panel Text For Carton Label: 

NDC 17478-660-30

Acetylcysteine

Injection

6 g/30 mL

(200 mg/mL)

Must be Further Diluted Prior to

Intravenous Use

Preservative Free

4 x 30 mL Single dose Vial

Sterile

Rx only Akorn Logo

Principal Display Panel Text for Carton Label
ACETYLCYSTEINE
acetylcysteine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-660
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetylcysteine(UNII: WYQ7N0BPYC) (Acetylcysteine - UNII:WYQ7N0BPYC)Acetylcysteine200 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
Edetate Disodium(UNII: 7FLD91C86K)0.5 mg in 1 mL
Sodium Hydroxide(UNII: 55X04QC32I)
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-660-304 in 1 CARTON03/25/2015
130 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20317303/25/2015
Labeler -Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.063434679PACK(17478-660) , LABEL(17478-660)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.155135783MANUFACTURE(17478-660) , ANALYSIS(17478-660) , STERILIZE(17478-660)

Revised: 11/2017document Id: 

ccd5f2d5-5934-49c2-b20a-34aeedaa0d2fSet id: 4072b547-c242-4a40-8c91-5481b86cbf1eVersion: 6Effective Time: 20171115Akorn, Inc.

Patient Information 

Sensitivity to acetylcysteine: Patients should be advised to report to their physician any history of sensitivity to acetylcysteine [see Contraindications (4)].

Asthma: Patients should be advised to report to their physician any history of asthma [see Warnings and Precautions (5)].

For all questions concerning adverse reactions associated with the use of this product or for inquiries concerning our products, please contact us at 1-866-634-9120. For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

*Sections or subsections omitted from the Full Prescribing Information are not listed.

US Patent Nos. 8,148,356 and 8,399,445. Patents pending.

Distributed By

Perrigo

Minneapolis, MN 55427

NOVAPLUS

N+ and NOVAPLUS are registered

trademarks of Novation, LLC.

9X400 7C J4

Rev 08-15 C



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