Prescription drug · ANDA
Albuterol Sulfate NDC 81894-105
Albuterol sulfate .63 mg/3mL · Solution · Respiratory (Inhalation) · Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81894-105-25 | 81894010525 | 5 POUCH in 1 CARTON (81894-105-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Apr 20, 2020 | |
| 81894-105-30 | 81894010530 | 6 POUCH in 1 CARTON (81894-105-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIALMarketed from Jul 29, 2024 |
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 Sulfate
- Generic name (nonproprietary)
- albuterol sulfate
- Active ingredients
- Albuterol sulfate — .63 mg/3mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211888
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 81894-105_1d6bfa3d-ae1f-8167-e063-6394a90a2356SPL ID 1d6bfa3d-ae1f-8167-e063-6394a90a2356SPL set ID 1d6be2b8-c670-b783-e063-6294a90ae503RxCUI 351136, 351137UNII 021SEF3731UPC 0381894106055, 0381894105058
- 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
N481894010525followed by a unit qualifier and the quantityPackage 81894-0105-25. 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 inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211888
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 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. | 81894-106 |
| Albuterol Sulfate | Albuterol sulfate .63 mg/3mL | SolutionRespiratory (Inhalation) | Aurobindo Pharma Limited | 59651-183 |
| Albuterol Sulfate | Albuterol sulfate 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Aurobindo Pharma Limited | 59651-184 |