Prescription drug · ANDA
Ipratropium Bromide And Albuterol Sulfate NDC 60687-405
Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL · Solution · Respiratory (Inhalation) · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-405-83 | 60687040583 | 30 POUCH in 1 CARTON (60687-405-83) / 1 AMPULE in 1 POUCH (60687-405-79) / 3 mL in 1 AMPULEMarketed from Jan 21, 2019 |
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
- American Health Packaging
- 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 60687-405_1a02568a-4fa8-5ec8-e063-6294a90a1558SPL ID 1a02568a-4fa8-5ec8-e063-6294a90a1558SPL set ID c04c6ec8-1401-424d-8126-63080e36c4b9RxCUI 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
N460687040583followed by a unit qualifier and the quantityPackage 60687-0405-83. 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.
Other NDCs under ANDA 202496
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 |
|---|---|---|---|---|
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Cipla USA Inc. | 69097-840 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Golden State Medical Supply, Inc. | 60429-975 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9671 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-1382 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Redpharm Drug | 67296-2315 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Ritedose Pharmaceuticals, LLC | 76204-600 |