Prescription drug · ANDA
Ipratropium Bromide and Albuterol Sulfate NDC 68788-8103
Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL · Solution · Respiratory (Inhalation) · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8103-3 | 68788810303 | 30 POUCH in 1 CARTON (68788-8103-3) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USEMarketed from Oct 14, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 3 mg/3mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076749
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 68788-8103_fbe77831-0248-4c6e-9289-52be8aeb234dSPL ID fbe77831-0248-4c6e-9289-52be8aeb234dSPL set ID 66f32a06-c880-4b5b-837b-951e1e01e040RxCUI 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
N468788810303followed by a unit qualifier and the quantityPackage 68788-8103-03. 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.
Other NDCs under ANDA 076749
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 | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-645 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Nephron Pharmaceuticals Corporation | 0487-0201 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Proficient Rx LP | 71205-051 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | Chartwell RX, LLC | 62135-831 |
| Ipratropium Bromide and Albuterol Sulfate | Ipratropium bromide .5 mg/3mL; Albuterol sulfate 3 mg/3mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-1669 |