NDC codes

FDA NDC Directory
Product NDC (as listed)69097-840Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69097-0840Add 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
69097-840-536909708405330 POUCH in 1 CARTON (69097-840-53) / 1 VIAL in 1 POUCH (69097-840-34) / 3 mL in 1 VIALMarketed from Jun 1, 2020
69097-840-64690970840642 POUCH in 1 CARTON (69097-840-64) / 30 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Jun 1, 2020
69097-840-87690970840871 POUCH in 1 CARTON (69097-840-87) / 30 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Jun 1, 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
Ipratropium bromide — .5 mg/3mLAlbuterol sulfate — 2.5 mg/3mL
Dosage form
Solution
Route
Respiratory (Inhalation)
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202496
Marketing start
Listing expires
Other FDA classes
Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 69097-840_14b7dfcc-b3a8-4027-9544-8d52ec2aacf3SPL ID 14b7dfcc-b3a8-4027-9544-8d52ec2aacf3SPL set ID 89d59bd9-c826-413c-8ed9-a1521a0c7cc5RxCUI 1437702UNII 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

N469097084053 followed by a unit qualifier and the quantity

Package 69097-0840-53. 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 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)

Other NDCs under ANDA 202496

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202496
ProductStrengthForm · routeLabelerProduct NDC
Ipratropium Bromide And Albuterol SulfateAlbuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mLSolutionRespiratory (Inhalation)Golden State Medical Supply, Inc.60429-975
Ipratropium Bromide and Albuterol SulfateIpratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)Mylan Pharmaceuticals Inc.0378-9671
Ipratropium Bromide And Albuterol SulfateAlbuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mLSolutionRespiratory (Inhalation)A-S Medication Solutions50090-1382
Ipratropium Bromide And Albuterol SulfateAlbuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mLSolutionRespiratory (Inhalation)American Health Packaging60687-405
Ipratropium Bromide And Albuterol SulfateAlbuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mLSolutionRespiratory (Inhalation)Redpharm Drug67296-2315
Ipratropium Bromide And Albuterol SulfateAlbuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mLSolutionRespiratory (Inhalation)Ritedose Pharmaceuticals, LLC76204-600

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