NDC codes

FDA NDC Directory
Product NDC (as listed)0409-3308Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-3308Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0409-3308-0300409330803004093308033 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.NDC labeler code 0409
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

N400409330803 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 0409-3308

What is NDC 0409-3308?
0409-3308 is the product NDC for Acetylcysteine, Acetylcysteine 200 mg/mL solution, listed with the FDA by Hospira, Inc.. 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?
Hospira, Inc., NDC labeler code 0409. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Acetylcysteine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AcetylcysteineAcetylcysteine 200 mg/mLInjection, SolutionIntravenousHikma Pharmaceuticals USA Inc.0143-943300143-9433-04
AcetylcysteineAcetylcysteine 100 mg/mLSolutionRespiratory (Inhalation)Cameron Pharmaceuticals42494-43542494-0435-25
AcetylcysteineAcetylcysteine 200 mg/mLSolutionRespiratory (Inhalation)Cameron Pharmaceuticals42494-43642494-0436-25
AcetylcysteineAcetylcysteine 100 mg/mLSolutionRespiratory (Inhalation)Somerset Therapeutics, LLC70069-01870069-0018-25
AcetylcysteineAcetylcysteine 200 mg/mLSolutionRespiratory (Inhalation)Somerset Therapeutics, LLC70069-01970069-0019-25
AcetylcysteineAcetylcysteine 200 mg/mLSolutionRespiratory (Inhalation)Somerset Therapeutics, LLC70069-02070069-0020-03
AcetylcysteineAcetylcysteine 200 mg/mLInjection, SolutionIntravenousGlenmark Pharmaceuticals Inc., USA68462-94668462-0946-12
AcetylcysteineAcetylcysteine 200 mg/mLInjection, SolutionIntravenousSomerset Therapeutics, LLC70069-78870069-0788-04
AcetylcysteineAcetylcysteine 200 mg/mLInjection, SolutionIntravenousXellia Pharmaceuticals USA LLC70594-11170594-0111-02
AcetylcysteineAcetylcysteine 200 mg/mLInjection, SolutionIntravenousONESOURCE SPECIALTY PHARMA LIMITED83270-00183270-0001-04

All 29 Acetylcysteine NDCs

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