Prescription drug · ANDA
Albuterol Sulfate NDC 59651-184
Albuterol sulfate 1.25 mg/3mL · Solution · Respiratory (Inhalation) · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-184-25 | 5965101842559651018425 | 5 POUCH in 1 CARTON (59651-184-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Apr 20, 2020 | |
| 59651-184-30 | 5965101843059651018430 | 6 POUCH in 1 CARTON (59651-184-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Jul 29, 2024 |
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 — 1.25 mg/3mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211888
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 59651-184_1e853c87-b534-65d2-e063-6394a90a7923SPL ID 1e853c87-b534-65d2-e063-6394a90a7923SPL set ID 78e6bee2-7113-46cf-8c97-dc61b0f7b94fRxCUI 351136, 351137UNII 021SEF3731UPC 0359651183052, 0359651184059
- 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
N459651018425followed by a unit qualifier and the quantityPackage 59651-0184-25. 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 to 12 years of age with asthma (reversible obstructive airway disease).
Excerpt only. Read the full label for complete information.
About NDC 59651-184
- What is NDC 59651-184?
- 59651-184 is the product NDC for Albuterol Sulfate, Albuterol sulfate 1.25 mg/3mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 2 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 211888
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 .63 mg/3mL | SolutionRespiratory (Inhalation) | Aurobindo Pharma Limited | 59651-183 |
| Albuterol Sulfate | Albuterol sulfate .63 mg/3mL | SolutionRespiratory (Inhalation) | Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. | 81894-105 |
| Albuterol Sulfate | Albuterol sulfate 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. | 81894-106 |