Prescription drug · ANDA
Albuterol Sulfate NDC 85766-127
Albuterol sulfate 2.5 mg/3mL · Solution · Respiratory (Inhalation) · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-127-01 | 8576601270185766012701 | 30 POUCH in 1 CARTON (85766-127-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 7, 2025 | |
| 85766-127-25 | 8576601272585766012725 | 1 POUCH in 1 CARTON (85766-127-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 7, 2025 | |
| 85766-127-30 | 8576601273085766012730 | 1 POUCH in 1 CARTON (85766-127-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 7, 2025 | |
| 85766-127-60 | 8576601276085766012760 | 2 POUCH in 1 CARTON (85766-127-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 7, 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 — 2.5 mg/3mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Sportpharm LLCNDC labeler code 85766
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074880
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 85766-127_5032431f-2259-7fb4-e063-6294a90ad0ffSPL ID 5032431f-2259-7fb4-e063-6294a90ad0ffSPL set ID a33e20e0-3936-450d-a9d9-3ff51c6f26c5RxCUI 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
N485766012701followed by a unit qualifier and the quantityPackage 85766-0127-01. 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 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.
About NDC 85766-127
- What is NDC 85766-127?
- 85766-127 is the product NDC for Albuterol Sulfate, Albuterol sulfate 2.5 mg/3mL solution, listed with the FDA by Sportpharm LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Albuterol Sulfate.
- What is the active ingredient?
- Albuterol sulfate.
- Who is the labeler?
- Sportpharm LLC, NDC labeler code 85766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Albuterol Sulfate?
- 91 other product NDCs are listed under this name. See all 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 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) |
|---|---|---|---|---|---|
| Albuterol Sulfate | Albuterol sulfate 108 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4528 | 70518-4528-00 |
| Albuterol Sulfate | Albuterol sulfate 90 ug/1 | InhalantRespiratory (Inhalation) | Preferred Pharmaceuticals, Inc. | 68788-4041 | 68788-4041-02 |
| Albuterol Sulfate | Albuterol sulfate 90 ug/1 | InhalantRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4496 | 70518-4496-00 |
| Albuterol Sulfate | Albuterol sulfate .83 mg/mL | SolutionRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4490 | 70518-4490-00 |
| Albuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Preferred Pharmaceuticals, Inc. | 68788-8878 | 68788-8878-02 |
| Albuterol Sulfate | Albuterol sulfate 90 ug/1 | InhalantRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8874 | 68788-8874-02 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/.5mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-642 | 64980-0642-03 |
| Albuterol Sulfate | Albuterol sulfate .63 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc | 64980-643 | 64980-0643-03 |
| Albuterol Sulfate | Albuterol sulfate 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc | 64980-644 | 64980-0644-02 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-641 | 64980-0641-0264980-0641-0364980-0641-06 |
Other NDCs under ANDA 074880
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 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Nephron Pharmaceuticals Corporation | 0487-9501 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-6560 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | HF Acquisition Co LLC, DBA HealthFirst | 51662-1499 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Chartwell RX, LLC | 62135-828 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Proficient Rx LP | 63187-204 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-641 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | NuCare Pharmaceuticals,Inc. | 68071-4543 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | NuCare Pharmaceuticals,Inc. | 68071-4754 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Asclemed USA, Inc. | 76420-087 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | ASCLEMED USA INC. | 87063-031 |