Prescription drug · ANDA
Ipratropium Bromide and Albuterol Sulfate NDC 69097-173
Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL · Solution · Respiratory (Inhalation) · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-173-53 | 6909701735369097017353 | 6 POUCH in 1 CARTON (69097-173-53) / 5 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Dec 31, 2007 | |
| 69097-173-64 | 6909701736469097017364 | 12 POUCH in 1 CARTON (69097-173-64) / 5 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Dec 31, 2007 |
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 and Albuterol Sulfate
- Generic name (nonproprietary)
- ipratropium bromide and albuterol sulfate
- Active ingredients
- Albuterol sulfate — 2.5 mg/3mLIpratropium bromide — .5 mg/3mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077559
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 69097-173_d98264d7-80fe-445f-ac85-2da23d9c374fSPL ID d98264d7-80fe-445f-ac85-2da23d9c374fSPL set ID 3c64255e-074c-41f8-a344-3686a0685020RxCUI 1437702UNII 021SEF3731, J697UZ2A9J
- 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
N469097017353followed by a unit qualifier and the quantityPackage 69097-0173-53. 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 69097-173
- What is NDC 69097-173?
- 69097-173 is the product NDC for Ipratropium Bromide and Albuterol Sulfate, Albuterol sulfate 2.5 mg/3mL; Ipratropium bromide .5 mg/3mL solution, listed with the FDA by Cipla USA Inc.. It has 2 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?
- Albuterol sulfate, Ipratropium bromide.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. 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 | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9671 | 00378-9671-3000378-9671-6000378-9671-93 |
| 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 |