Prescription drug · ANDA
Albuterol NDC 69238-1344
Albuterol sulfate 2 mg/1 · Tablet · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1344-1 | 69238134401 | 100 TABLET in 1 BOTTLE (69238-1344-1)Marketed from May 24, 2018 | |
| 69238-1344-5 | 69238134405 | 500 TABLET in 1 BOTTLE (69238-1344-5)Marketed from May 24, 2018 |
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
- Generic name (nonproprietary)
- albuterol
- Active ingredients
- Albuterol sulfate — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208804
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 69238-1344_efcb5cab-b9c0-4ef9-84fc-5f321c13a0edSPL ID efcb5cab-b9c0-4ef9-84fc-5f321c13a0edSPL set ID 230d66fc-f62c-42a6-adb3-0a0f879c8ad4RxCUI 197316, 197318UNII 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
N469238134401followed by a unit qualifier and the quantityPackage 69238-1344-01. 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 tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208804
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 | Albuterol sulfate 4 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1345 |