Prescription drug · ANDA
Ipratropium Bromide NDC 76204-100
Ipratropium bromide .5 mg/2.5mL · Solution · Respiratory (Inhalation) · Ritedose Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76204-100-01 | 76204010001 | 30 POUCH in 1 CARTON (76204-100-01) / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 21, 2011 | |
| 76204-100-25 | 76204010025 | 1 POUCH in 1 CARTON (76204-100-25) / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 21, 2011 | |
| 76204-100-30 | 76204010030 | 1 POUCH in 1 CARTON (76204-100-30) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 21, 2011 | |
| 76204-100-60 | 76204010060 | 2 POUCH in 1 CARTON (76204-100-60) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 21, 2011 |
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)
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075693
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 76204-100_459b984d-b299-c7c0-e063-6294a90a3efdSPL ID 459b984d-b299-c7c0-e063-6294a90a3efdSPL set ID 22479633-624a-4251-ad3c-1dcba5d503fbRxCUI 836358UNII J697UZ2A9JUPC 0376204100250, 0376204100014
- 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
N476204010001followed by a unit qualifier and the quantityPackage 76204-0100-01. 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 075693
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) | A-S Medication Solutions | 50090-6373 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-7970 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-0668 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Cardinal Health 107, LLC | 55154-4411 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Redpharm Drug | 67296-2246 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Cardinal Health 107, LLC | 55154-2134 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | NuCare Pharmaceuticals, Inc. | 68071-3769 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | American Health Packaging | 60687-394 |