NDC codes

FDA NDC Directory
Product NDC (as listed)0597-0024Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00597-0024Add 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
0597-0024-0200597002402005970024021 CARTRIDGE in 1 CARTON (0597-0024-02) / 120 SPRAY, METERED in 1 CARTRIDGEMarketed from Jul 1, 2012

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)
Combivent Respimat
Generic name (nonproprietary)
ipratropium bromide and albuterol
Active ingredients
Ipratropium bromide — 20 ug/1Albuterol sulfate — 100 ug/1
Dosage form
Spray, Metered
Route
Respiratory (Inhalation)
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021747
Marketing start
Listing expires
Other FDA classes
Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 0597-0024_aa423748-811c-4bf7-a67f-b38cf394553fSPL ID aa423748-811c-4bf7-a67f-b38cf394553fSPL set ID 9832312e-0310-4ab6-8501-afa976fc7eb2RxCUI 1190220, 1190225UNII J697UZ2A9J, 021SEF3731
Pharmacologic class
Anticholinergic; beta2-Adrenergic Agonist

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

N400597002402 followed by a unit qualifier and the quantity

Package 00597-0024-02. 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)

COMBIVENT RESPIMAT is a combination of ipratropium bromide (an anticholinergic agent) and albuterol sulfate (a beta 2 -adrenergic agonist) indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. COMBIVENT RESPIMAT Inhalation Spray is a combination of ipratropium bromide (an anticholinergic agent) and albuterol sulfate (a beta 2 ‑adrenergic agonist) indicated for: Patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator (1)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0597-0024

What is NDC 0597-0024?
0597-0024 is the product NDC for Combivent Respimat, Ipratropium bromide 20 ug/1; Albuterol sulfate 100 ug/1 spray, metered, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Combivent Respimat (Ipratropium bromide and albuterol).
What is the active ingredient?
Ipratropium bromide, Albuterol sulfate.
Who is the labeler?
Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Combivent Respimat?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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