Prescription drug · ANDA
Ipratropium Bromide NDC 0378-7970
Ipratropium bromide .5 mg/2.5mL · Solution · Respiratory (Inhalation) · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7970-52 | 0037879705200378797052 | 1 POUCH in 1 CARTON (0378-7970-52) / 25 AMPULE in 1 POUCH (0378-7970-62) / 2.5 mL in 1 AMPULEMarketed from Nov 9, 2010 | |
| 0378-7970-55 | 0037879705500378797055 | 30 POUCH in 1 CARTON (0378-7970-55) / 1 AMPULE in 1 POUCH (0378-7970-31) / 2.5 mL in 1 AMPULEMarketed from Nov 9, 2010 | |
| 0378-7970-91 | 0037879709100378797091 | 2 POUCH in 1 CARTON (0378-7970-91) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULEMarketed from Nov 9, 2010 | |
| 0378-7970-93 | 0037879709300378797093 | 1 POUCH in 1 CARTON (0378-7970-93) / 30 AMPULE in 1 POUCH (0378-7970-64) / 2.5 mL in 1 AMPULEMarketed from Nov 9, 2010 |
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
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- 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 0378-7970_2c5fc3b9-e3f3-4120-947a-815d30502a3aSPL ID 2c5fc3b9-e3f3-4120-947a-815d30502a3aSPL set ID f625d3e3-c175-4d9a-99ea-dab410b262f1RxCUI 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
N400378797052followed by a unit qualifier and the quantityPackage 00378-7970-52. 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 0378-7970
- What is NDC 0378-7970?
- 0378-7970 is the product NDC for Ipratropium Bromide, Ipratropium bromide .5 mg/2.5mL solution, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 4 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 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 | 50090-0668 |
| 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) | Cardinal Health 107, LLC | 55154-2134 |
| 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) | American Health Packaging | 60687-394 |
| Ipratropium Bromide | Ipratropium bromide .5 mg/2.5mL | SolutionRespiratory (Inhalation) | Redpharm Drug | 67296-2246 |
| 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) | Ritedose Pharmaceuticals, LLC | 76204-100 |