NDC 63323-690

Acetylcysteine

Acetylcysteine

Acetylcysteine is a Oral; Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Acetylcysteine.

• Product ID: 63323-690_05c9a4dd-4070-4725-8ee8-3c9484faf96e
• NDC: 63323-690
• Product Type: Human Prescription Drug
• Proprietary Name: Acetylcysteine
• Generic Name: Acetylcysteine
• Dosage Form: Solution
• Route of Administration: ORAL; RESPIRATORY (INHALATION)
• Marketing Start Date: 2012-09-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203853
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: ACETYLCYSTEINE
• Active Ingredient Strength: 200 mg/mL
• Pharm 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: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63323-690-30

3 VIAL in 1 CARTON (63323-690-30) > 30 mL in 1 VIAL

• Marketing Start Date: 2012-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-690-44 [63323069044]

Acetylcysteine SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203853
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-09-01

NDC 63323-690-30 [63323069030]

Acetylcysteine SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203853
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-09-01

NDC 63323-690-41 [63323069041]

Acetylcysteine SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203853
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-09-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETYLCYSTEINE	200 mg/mL

OpenFDA Data

• SPL SET ID: 75b48fab-cef6-465c-a1e0-d085b3988bc4
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • WYQ7N0BPYC
• RxNorm Concept Unique ID - RxCUI:
  • 307718
  • 307719
• UPC Code:
  • 0363323692100
  • 0363323694043
  • 0363323690304
  • 0363323695040
  • 0363323693107
  • 0363323691301

Pharmacological Class

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

Medicade Reported Pricing

63323069030 ACETYLCYSTEINE 20% VIAL

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Acetylcysteine" or generic name "Acetylcysteine"

NDC	Brand Name	Generic Name
0409-3307	Acetylcysteine	ACETYLCYSTEINE
0409-3308	Acetylcysteine	ACETYLCYSTEINE
0517-7504	Acetylcysteine	acetylcysteine
0517-7510	Acetylcysteine	acetylcysteine
0517-7604	Acetylcysteine	acetylcysteine
0517-7610	Acetylcysteine	acetylcysteine
0517-7630	Acetylcysteine	acetylcysteine
0574-0805	acetylcysteine	Acetylcysteine
0574-0815	Acetylcysteine	acetylcysteine
14445-412	ACETYLCYSTEINE	ACETYLCYSTEINE
17478-660	Acetylcysteine	Acetylcysteine
25021-812	Acetylcysteine	acetylcysteine
51754-0104	Acetylcysteine	Acetylcysteine Injection
55150-259	Acetylcysteine	Acetylcysteine
55154-5730	Acetylcysteine	Acetylcysteine
70710-1015	ACETYLCYSTEINE	ACETYLCYSTEINE
70771-1412	ACETYLCYSTEINE	ACETYLCYSTEINE
55154-5731	Acetylcysteine	Acetylcysteine
63323-690	Acetylcysteine	Acetylcysteine
63323-693	Acetylcysteine	Acetylcysteine
63323-694	Acetylcysteine	Acetylcysteine
63323-963	Acetylcysteine	Acetylcysteine
63323-692	Acetylcysteine	Acetylcysteine
63323-691	Acetylcysteine	Acetylcysteine
63323-695	Acetylcysteine	Acetylcysteine
24338-700	Cetylev	acetylcysteine
24338-707	Cetylev	acetylcysteine
24338-725	Cetylev	acetylcysteine