Prescription drug · ANDA
albuterol sulfate NDC 53489-177
Albuterol sulfate 4 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53489-177-01 | 5348901770153489017701 | 100 TABLET in 1 BOTTLE (53489-177-01)Marketed from Dec 5, 1989 | |
| 53489-177-02 | 5348901770253489017702 | 50 TABLET in 1 BOTTLE (53489-177-02)Marketed from Dec 5, 1989 | |
| 53489-177-03 | 5348901770353489017703 | 250 TABLET in 1 BOTTLE (53489-177-03)Marketed from Dec 5, 1989 | |
| 53489-177-05 | 5348901770553489017705 | 500 TABLET in 1 BOTTLE (53489-177-05)Marketed from Dec 5, 1989 | |
| 53489-177-10 | 5348901771053489017710 | 1000 TABLET in 1 BOTTLE (53489-177-10)Marketed from Dec 5, 1989 |
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 — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 53489
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072637
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 53489-177_4d289f6d-634d-2125-e063-6394a90aa25dSPL ID 4d289f6d-634d-2125-e063-6394a90aa25dSPL set ID 87b8cd3c-2849-4b50-b63e-9ea379165c07RxCUI 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
N453489017701followed by a unit qualifier and the quantityPackage 53489-0177-01. 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 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.
About NDC 53489-177
- What is NDC 53489-177?
- 53489-177 is the product NDC for albuterol sulfate, Albuterol sulfate 4 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 5 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 53489. 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 072637
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/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-367 |
| albuterol sulfate | Albuterol sulfate 4 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-368 |
| albuterol sulfate | Albuterol sulfate 2 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-176 |
| Albuterol Sulfate | Albuterol sulfate 2 mg/1 | TabletOral | American Health Packaging | 68084-949 |