Prescription drug · ANDA
Albuterol NDC 64980-442
Albuterol sulfate 2 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-442-01 | 64980044201 | 100 TABLET in 1 BOTTLE (64980-442-01)Marketed from Jun 29, 2018 | |
| 64980-442-50 | 64980044250 | 500 TABLET in 1 BOTTLE (64980-442-50)Marketed from Jun 29, 2018 |
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
- Active ingredients
- Albuterol sulfate — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207046
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 64980-442_f3d2f709-6e2e-4c25-8069-52661dc76e2dSPL ID f3d2f709-6e2e-4c25-8069-52661dc76e2dSPL set ID 40f3cdbc-c9ee-4a3c-8061-a44b9a1d035cRxCUI 197316, 197318UNII 021SEF3731UPC 0364980443500, 0364980443012
- 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
N464980044201followed by a unit qualifier and the quantityPackage 64980-0442-01. 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 & USAGE Albuterol tablets 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 207046
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 | Rising Pharma Holdings, Inc. | 64980-443 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Proficient Rx LP | 71205-898 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Proficient Rx LP | 71205-899 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2611 |