Prescription drug · ANDA
Acetylcysteine NDC 55154-5731
Acetylcysteine 200 mg/mL · Inhalant · Respiratory (Inhalation) · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-5731-5 | 55154573105 | 5 VIAL, GLASS in 1 BAG (55154-5731-5) / 4 mL in 1 VIAL, GLASSMarketed from May 6, 2011 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Inhalant
- Route
- Respiratory (Inhalation)
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072547
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Glutathione Concentration (Physiologic effect)Reduction Activity (Mechanism)
- Identifiers
- Product ID 55154-5731_1c27f160-8d78-462c-91e6-c9a89b7dc4a2SPL ID 1c27f160-8d78-462c-91e6-c9a89b7dc4a2SPL set ID c90fca12-12fb-4cf6-bd6f-83bc0d95df81RxCUI 307718, 307719UNII WYQ7N0BPYCUPC 0055154573054, 0055154573153
- 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
N455154573105followed by a unit qualifier and the quantityPackage 55154-5731-05. 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.
About NDC 55154-5731
- What is NDC 55154-5731?
- 55154-5731 is the product NDC for Acetylcysteine, Acetylcysteine 200 mg/mL inhalant, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetylcysteine.
- What is the active ingredient?
- Acetylcysteine.
- Who is the labeler?
- Cardinal Health 107, LLC, NDC labeler code 55154. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetylcysteine?
- 28 other product NDCs are listed under this name. See all Acetylcysteine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetylcysteine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9433 | 00143-9433-04 |
| Acetylcysteine | Acetylcysteine 100 mg/mL | SolutionRespiratory (Inhalation) | Cameron Pharmaceuticals | 42494-435 | 42494-0435-25 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | SolutionRespiratory (Inhalation) | Cameron Pharmaceuticals | 42494-436 | 42494-0436-25 |
| Acetylcysteine | Acetylcysteine 100 mg/mL | SolutionRespiratory (Inhalation) | Somerset Therapeutics, LLC | 70069-018 | 70069-0018-25 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | SolutionRespiratory (Inhalation) | Somerset Therapeutics, LLC | 70069-019 | 70069-0019-25 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | SolutionRespiratory (Inhalation) | Somerset Therapeutics, LLC | 70069-020 | 70069-0020-03 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | Glenmark Pharmaceuticals Inc., USA | 68462-946 | 68462-0946-12 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-788 | 70069-0788-04 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-111 | 70594-0111-02 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | Injection, SolutionIntravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-001 | 83270-0001-04 |
Other NDCs under ANDA 072547
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acetylcysteine | Acetylcysteine 200 mg/mL | InhalantRespiratory (Inhalation) | American Regent, Inc. | 0517-7604 |
| Acetylcysteine | Acetylcysteine 200 mg/mL | InhalantRespiratory (Inhalation) | American Regent, Inc. | 0517-7610 |