Prescription drug · ANDA
Albuterol Sulfate Inhalation (albuterol sulfate) NDC 69238-1291
Albuterol sulfate 90 ug/1 · Inhalant · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1291-1 | 69238129101 | 1 CANISTER in 1 CARTON (69238-1291-1) / 200 INHALANT in 1 CANISTERMarketed from Dec 3, 2025 |
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)
- Albuterol Sulfate Inhalation
- Generic name (nonproprietary)
- albuterol sulfate
- Active ingredients
- Albuterol sulfate — 90 ug/1
- Dosage form
- Inhalant
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211600
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 69238-1291_881ca107-7a62-40e0-8936-89bc2d16cfa6SPL ID 881ca107-7a62-40e0-8936-89bc2d16cfa6SPL set ID 2e449282-ee58-4e36-b983-85c4e6f0864dRxCUI 2123072UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469238129101followed by a unit qualifier and the quantityPackage 69238-1291-01. 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)
Albuterol Sulfate Inhalation Aeroso is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2 ) 1.1 Bronchospasm Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
Excerpt only. Read the full label for complete information.