Prescription drug · ANDA
Albuterol (Albuterol sulfate) NDC 69097-021
Albuterol sulfate 90 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-021-60 | 6909700216069097002160 | 1 INHALER in 1 CARTON (69097-021-60) / 200 AEROSOL, METERED in 1 INHALERMarketed from Apr 22, 2026 |
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
- Generic name (nonproprietary)
- albuterol sulfate
- Active ingredients
- Albuterol sulfate — 90 ug/1
- Dosage form
- Aerosol, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219409
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 69097-021_7d4c1e96-c05f-4ffc-80b6-988986a061bcSPL ID 7d4c1e96-c05f-4ffc-80b6-988986a061bcSPL set ID fd0389e0-3713-42e0-8ef2-3bb97676fdedRxCUI 2123076UNII 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
N469097002160followed by a unit qualifier and the quantityPackage 69097-0021-60. 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 aerosol is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2 ) 1.1 Bronchospasm Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years 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 adult an…
Excerpt only. Read the full label for complete information.
About NDC 69097-021
- What is NDC 69097-021?
- 69097-021 is the product NDC for Albuterol (albuterol sulfate), Albuterol sulfate 90 ug/1 aerosol, metered, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Albuterol (Albuterol Sulfate).
- What is the active ingredient?
- Albuterol sulfate.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. 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?
- 15 other product NDCs are listed under this name. See all Albuterol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Albuterol 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 | Albuterol sulfate .63 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-7057 | 00378-7057-52 |
| Albuterol | Albuterol sulfate 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-7058 | 00378-7058-52 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1061 | 70710-1061-01 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1062 | 70710-1062-0170710-1062-05 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1511 | 70771-1511-01 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1512 | 70771-1512-0170771-1512-05 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-333 | 59651-0333-0159651-0333-05 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-334 | 59651-0334-0159651-0334-05 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2611 | 63629-2611-0163629-2611-0263629-2611-03 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-442 | 64980-0442-0164980-0442-50 |