Prescription drug · ANDA
Albuterol Sulfate NDC 71335-2907
Albuterol sulfate 2 mg/5mL · Syrup · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2907-1 | 71335290701 | 473 mL in 1 BOTTLE (71335-2907-1)Marketed from Nov 10, 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
- Generic name (nonproprietary)
- albuterol sulfate
- Active ingredients
- Albuterol sulfate — 2 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212197
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 71335-2907_474dd04b-2935-4af1-a309-958c00f08193SPL ID 474dd04b-2935-4af1-a309-958c00f08193SPL set ID 378461f2-7271-44a3-9da3-b39970b65d3aRxCUI 755497UNII 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
N471335290701followed by a unit qualifier and the quantityPackage 71335-2907-01. 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 Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212197
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 2 mg/5mL | SyrupOral | QUAGEN PHARMACEUTICALS LLC | 70752-102 |
| Albuterol Sulfate | Albuterol sulfate 2 mg/5mL | SyrupOral | Preferred Pharmaceuticals, Inc. | 68788-7573 |
| Albuterol Sulfate | Albuterol sulfate 2 mg/5mL | SyrupOral | Bryant Ranch Prepack | 72162-2064 |