Prescription drug · ANDA
Ipratropium Bromide and Albuterol Sulfate NDC 0378-9671
Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL · Solution · Respiratory (Inhalation) · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-9671-30 | 0037896713000378967130 | 1 POUCH in 1 CARTON (0378-9671-30) / 30 AMPULE in 1 POUCH (0378-9671-64) / 3 mL in 1 AMPULEMarketed from Mar 1, 2013 | |
| 0378-9671-60 | 0037896716000378967160 | 2 POUCH in 1 CARTON (0378-9671-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULEMarketed from Mar 1, 2013 | |
| 0378-9671-93 | 0037896719300378967193 | 30 POUCH in 1 CARTON (0378-9671-93) / 1 AMPULE in 1 POUCH (0378-9671-31) / 3 mL in 1 AMPULEMarketed from Mar 1, 2013 |
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 and Albuterol Sulfate
- Generic name (nonproprietary)
- ipratropium bromide and albuterol sulfate
- Active ingredients
- Ipratropium bromide — .5 mg/3mLAlbuterol sulfate — 2.5 mg/3mL
- 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 202496
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 0378-9671_96603d2c-6783-4f6c-8b3e-de3eaabcc6aaSPL ID 96603d2c-6783-4f6c-8b3e-de3eaabcc6aaSPL set ID 23c05e9a-9df5-4978-8831-cf562aa4ba92RxCUI 1437702UNII J697UZ2A9J, 021SEF3731
- Pharmacologic class
- Anticholinergic; beta2-Adrenergic Agonist
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
N400378967130followed by a unit qualifier and the quantityPackage 00378-9671-30. 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 and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
Excerpt only. Read the full label for complete information.
About NDC 0378-9671
- What is NDC 0378-9671?
- 0378-9671 is the product NDC for Ipratropium Bromide and Albuterol Sulfate, Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL solution, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ipratropium Bromide and Albuterol Sulfate.
- What is the active ingredient?
- Ipratropium bromide, Albuterol sulfate.
- 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 and Albuterol Sulfate?
- 16 other product NDCs are listed under this name. See all Ipratropium Bromide and Albuterol Sulfate 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 and Albuterol Sulfate 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 and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-645 | 64980-0645-0364980-0645-06 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Sun Pharmaceutical Industries, Inc. | 47335-756 | 47335-0756-4947335-0756-52 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Proficient Rx LP | 71205-726 | 71205-0726-15 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8103 | 68788-8103-03 |
| Ipratropium Bromide and Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Aurobindo Pharma Limited | 65862-906 | 65862-0906-0365862-0906-3065862-0906-60 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Cipla USA Inc. | 69097-840 | 69097-0840-5369097-0840-6469097-0840-87 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | American Health Packaging | 60687-405 | 60687-0405-83 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-1382 | 50090-1382-00 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Redpharm Drug | 67296-2315 | 67296-2315-09 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Ritedose Pharmaceuticals, LLC | 76204-600 | 76204-0600-0176204-0600-0576204-0600-12+2 more |
Other NDCs under ANDA 202496
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 And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-1382 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Golden State Medical Supply, Inc. | 60429-975 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | American Health Packaging | 60687-405 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Redpharm Drug | 67296-2315 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Cipla USA Inc. | 69097-840 |
| Ipratropium Bromide And Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL | SolutionRespiratory (Inhalation) | Ritedose Pharmaceuticals, LLC | 76204-600 |