Prescription drug · ANDA
Ipratropium Bromide NDC 62135-830
Ipratropium bromide .5 mg/2.5mL · Solution · Respiratory (Inhalation) · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-830-84 | 62135083084 | 6 POUCH in 1 CARTON (62135-830-84) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIALMarketed 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
- Generic name (nonproprietary)
- ipratropium bromide
- Active ingredients
- Ipratropium bromide — .5 mg/2.5mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075562
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 62135-830_44fdbe83-0583-3b33-e063-6394a90a66dbSPL ID 44fdbe83-0583-3b33-e063-6394a90a66dbSPL set ID 1e3d4faa-cf6e-460b-b1e0-fcc8094505faRxCUI 836358UNII J697UZ2A9J
- Pharmacologic class
- Anticholinergic
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
N462135083084followed by a unit qualifier and the quantityPackage 62135-0830-84. 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 inhalation solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075562
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 | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-640 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Nephron Pharmaceuticals Corporation | 0487-9801 |