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 | 0048798010100487980101 | 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 | 0048798010200487980102 | 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 | 0048798012500487980125 | 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 | 0048798013000487980130 | 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 | 0048798016000487980160 | 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)
- Labeler
- Nephron Pharmaceuticals CorporationNDC labeler code 0487
- 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.
About NDC 0487-9801
- What is NDC 0487-9801?
- 0487-9801 is the product NDC for Ipratropium Bromide, Ipratropium bromide .5 mg/2.5mL solution, listed with the FDA by Nephron Pharmaceuticals Corporation. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ipratropium Bromide.
- What is the active ingredient?
- Ipratropium bromide.
- Who is the labeler?
- Nephron Pharmaceuticals Corporation, NDC labeler code 0487. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ipratropium Bromide?
- 32 other product NDCs are listed under this name. See all Ipratropium Bromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ipratropium Bromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Cardinal Health 107, LLC | 55154-4411 | 55154-4411-05 |
| Ipratropium Bromide | Ipratropium bromide 21 ug/1 | Spray, MeteredNasal | Lupin Pharmaceuticals, Inc. | 70748-336 | 70748-0336-01 |
| Ipratropium Bromide | Ipratropium bromide 42 ug/1 | Spray, MeteredNasal | Lupin Pharmaceuticals, Inc. | 70748-337 | 70748-0337-01 |
| Ipratropium Bromide | Ipratropium bromide 42 ug/1 | Spray, MeteredNasal | Sportpharm LLC | 85766-242 | 85766-0242-15 |
| Ipratropium Bromide | Ipratropium bromide 42 ug/1 | Spray, MeteredNasal | Oceanside Pharmaceuticals | 68682-399 | 68682-0399-15 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-640 | 64980-0640-0264980-0640-0364980-0640-06 |
| Ipratropium Bromide | Ipratropium bromide 21 ug/1 | Spray, MeteredNasal | Advagen Pharma Ltd | 72888-149 | 72888-0149-38 |
| Ipratropium Bromide | Ipratropium bromide 42 ug/1 | Spray, MeteredNasal | Advagen Pharma Ltd | 72888-148 | 72888-0148-37 |
| Ipratropium Bromide | Ipratropium bromide 21 ug/1 | SprayNasal | Amneal Pharmaceuticals NY LLC | 69238-2016 | 69238-2016-03 |
| Ipratropium Bromide | Ipratropium bromide 42 ug/1 | SprayNasal | Amneal Pharmaceuticals NY LLC | 69238-2017 | 69238-2017-02 |
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) | Chartwell RX, LLC | 62135-830 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-640 |