Prescription drug · ANDA
Albuterol Sulfate NDC 81894-104
Albuterol sulfate .83 mg/mL · Solution · Respiratory (Inhalation) · Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81894-104-02 | 8189401040281894010402 | 30 POUCH in 1 CARTON (81894-104-02) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 17, 2017 | |
| 81894-104-25 | 8189401042581894010425 | 5 POUCH in 1 CARTON (81894-104-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 17, 2017 | |
| 81894-104-30 | 8189401043081894010430 | 6 POUCH in 1 CARTON (81894-104-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 17, 2017 | |
| 81894-104-60 | 8189401046081894010460 | 12 POUCH in 1 CARTON (81894-104-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 17, 2017 |
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 — .83 mg/mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.NDC labeler code 81894
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206224
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 81894-104_5b80e7da-01a7-6709-e063-6294a90adb9dSPL ID 5b80e7da-01a7-6709-e063-6294a90adb9d
- 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
N481894010402followed by a unit qualifier and the quantityPackage 81894-0104-02. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 81894-104
- What is NDC 81894-104?
- 81894-104 is the product NDC for Albuterol Sulfate, Albuterol sulfate .83 mg/mL solution, listed with the FDA by Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Albuterol Sulfate.
- What is the active ingredient?
- Albuterol sulfate.
- Who is the labeler?
- Luoxin Aurovitas Pharma (Chengdu) Co., Ltd., NDC labeler code 81894. 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 Sulfate?
- 91 other product NDCs are listed under this name. See all Albuterol Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Albuterol Sulfate 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 Sulfate | Albuterol sulfate 108 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4528 | 70518-4528-00 |
| Albuterol Sulfate | Albuterol sulfate 90 ug/1 | InhalantRespiratory (Inhalation) | Preferred Pharmaceuticals, Inc. | 68788-4041 | 68788-4041-02 |
| Albuterol Sulfate | Albuterol sulfate 90 ug/1 | InhalantRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4496 | 70518-4496-00 |
| Albuterol Sulfate | Albuterol sulfate .83 mg/mL | SolutionRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4490 | 70518-4490-00 |
| Albuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Preferred Pharmaceuticals, Inc. | 68788-8878 | 68788-8878-02 |
| Albuterol Sulfate | Albuterol sulfate 90 ug/1 | InhalantRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8874 | 68788-8874-02 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/.5mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-642 | 64980-0642-03 |
| Albuterol Sulfate | Albuterol sulfate .63 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc | 64980-643 | 64980-0643-03 |
| Albuterol Sulfate | Albuterol sulfate 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc | 64980-644 | 64980-0644-02 |
| Albuterol Sulfate | Albuterol sulfate 2.5 mg/3mL | SolutionRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-641 | 64980-0641-0264980-0641-0364980-0641-06 |
Other NDCs under ANDA 206224
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 .83 mg/mL | SolutionRespiratory (Inhalation) | Aurobindo Pharma Limited | 65862-858 |
| Albuterol Sulfate | Albuterol sulfate .83 mg/mL | SolutionRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4490 |