Prescription drug · ANDA
Acetylcysteine NDC 0409-3308
Acetylcysteine 200 mg/mL · Solution · Oral, Respiratory (Inhalation) · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-3308-03 | 00409330803 | 3 VIAL in 1 CARTON (0409-3308-03) / 30 mL in 1 VIAL (0409-3308-11)Marketed from Jun 1, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Acetylcysteine
- Generic name (nonproprietary)
- acetylcysteine
- Active ingredients
- Acetylcysteine — 200 mg/mL
- Dosage form
- Solution
- Route
- Oral, Respiratory (Inhalation)
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074037
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Glutathione Concentration (Physiologic effect)Reduction Activity (Mechanism)
- Identifiers
- Product ID 0409-3308_6c12470d-0f1a-4085-938d-121df34c3cb0SPL ID 6c12470d-0f1a-4085-938d-121df34c3cb0SPL set ID 5558a5f5-e821-473b-7d8a-5d33d09f0586RxCUI 307718, 307719UNII WYQ7N0BPYC
- Pharmacologic class
- Antidote; Antidote for Acetaminophen Overdose; Mucolytic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400409330803followed by a unit qualifier and the quantityPackage 00409-3308-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung) Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis) Pulmonary complications of cystic fibrosis Tracheostomy care Pulmonary complications associated with surgery Use during anesthesia Post-traumatic chest conditions Atelectasis due to mucous obstruction Diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge cath…
Excerpt only. Read the full label for complete information.