Ipratropium Bromide and Albuterol Sulfate NDC 65862-906

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-906Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0906Add 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 NDC	11-digit (billing)	Package
65862-906-03	65862090603	30 POUCH in 1 CARTON (65862-906-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 9, 2020
65862-906-30	65862090630	6 POUCH in 1 CARTON (65862-906-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 9, 2020
65862-906-60	65862090660	12 POUCH in 1 CARTON (65862-906-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 9, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Ipratropium Bromide and Albuterol Sulfate
Generic name (nonproprietary): ipratropium bromide and albuterol sulfate
Active ingredients: Albuterol sulfate — 2.5 mg/3mLIpratropium bromide — .5 mg/3mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206532
Marketing start: Jul 9, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 65862-906_08febdad-3a3d-f105-e063-6294a90a0b3bSPL ID 08febdad-3a3d-f105-e063-6294a90a0b3bSPL set ID 370516c4-718f-4a71-bdc8-8822060ccefeRxCUI 1437702UNII 021SEF3731, J697UZ2A9J
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

N465862090603 followed by a unit qualifier and the quantity

Package 65862-0906-03. 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 Oct 31, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)