Prescription drug · ANDA
Ipratropium Bromide NDC 0487-9801
Ipratropium bromide .5 mg/2.5mL · Solution · Respiratory (Inhalation) · Nephron Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0487-9801-01 | 00487980101 | 30 POUCH in 1 CARTON (0487-9801-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001 | |
| 0487-9801-02 | 00487980102 | 30 BAG in 1 BOX (0487-9801-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001 | |
| 0487-9801-25 | 00487980125 | 1 POUCH in 1 CARTON (0487-9801-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001 | |
| 0487-9801-30 | 00487980130 | 1 POUCH in 1 CARTON (0487-9801-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001 | |
| 0487-9801-60 | 00487980160 | 2 POUCH in 1 CARTON (0487-9801-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 27, 2001 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 075562
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 0487-9801_3249e47e-0ac1-e2a5-e063-6394a90a9993SPL ID 3249e47e-0ac1-e2a5-e063-6394a90a9993SPL set ID db8095db-d1fd-4099-9fb1-d1ad4e284976RxCUI 836358UNII J697UZ2A9JUPC 0304879801011, 0304879801004
- 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
N400487980101followed by a unit qualifier and the quantityPackage 00487-9801-01. 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 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) | Chartwell RX, LLC | 62135-830 |