Prescription drug · ANDA
Albuterol Sulfate NDC 71205-641
Albuterol sulfate .83 mg/mL · Solution · Respiratory (Inhalation) · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-641-25 | 71205064125 | 5 POUCH in 1 CARTON (71205-641-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Feb 25, 2022 | |
| 71205-641-30 | 71205064130 | 6 POUCH in 1 CARTON (71205-641-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Apr 8, 2025 |
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)
- Albuterol Sulfate
- Generic name (nonproprietary)
- albuterol sulfate
- Active ingredients
- Albuterol sulfate — .83 mg/mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207857
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 71205-641_4263a4e9-a9d9-40da-ad2c-c75c82976319SPL ID 4263a4e9-a9d9-40da-ad2c-c75c82976319SPL set ID a6545fbe-b0a6-41ae-8bb6-91af38410f56RxCUI 630208UNII 021SEF3731
- Pharmacologic class
- 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
N471205064125followed by a unit qualifier and the quantityPackage 71205-0641-25. 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 Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207857
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 |
|---|---|---|---|---|
| Albuterol Sulfate | Albuterol sulfate .83 mg/mL | SolutionRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8492 |
| Albuterol Sulfate | Albuterol sulfate .83 mg/mL | SolutionRespiratory (Inhalation) | Sun Pharmaceutical Industries, Inc. | 47335-703 |
| Albuterol Sulfate | Albuterol sulfate .83 mg/mL | SolutionRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-3560 |