Prescription drug · ANDA
Ipratropium Bromide and Albuterol Sulfate NDC 62135-831
Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL · Solution · Respiratory (Inhalation) · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-831-84 | 62135083184 | 6 POUCH in 1 CARTON (62135-831-84) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 25, 2024 |
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 — 3 mg/3mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076749
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 62135-831_44fdd133-41a7-3c7b-e063-6394a90a65d1SPL ID 44fdd133-41a7-3c7b-e063-6394a90a65d1SPL set ID b444478a-10ce-484f-9039-6383dfb8161eRxCUI 1437702UNII J697UZ2A9J, 021SEF3731UPC 0362135831844
- 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
N462135083184followed by a unit qualifier and the quantityPackage 62135-0831-84. 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 076749
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 3 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-645 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8103 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Nephron Pharmaceuticals Corporation | 0487-0201 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Proficient Rx LP | 71205-051 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-1669 |