albuterol sulfate NDC 53489-176

NDC codes

FDA NDC Directory

Product NDC (as listed)53489-176Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53489-0176Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
53489-176-01	53489017601	100 TABLET in 1 BOTTLE (53489-176-01)Marketed from Dec 5, 1989
53489-176-02	53489017602	50 TABLET in 1 BOTTLE (53489-176-02)Marketed from Dec 5, 1989
53489-176-03	53489017603	250 TABLET in 1 BOTTLE (53489-176-03)Marketed from Dec 5, 1989
53489-176-05	53489017605	500 TABLET in 1 BOTTLE (53489-176-05)Marketed from Dec 5, 1989
53489-176-10	53489017610	1000 TABLET in 1 BOTTLE (53489-176-10)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 — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072637
Marketing start: Dec 5, 1989
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 53489-176_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

N453489017601 followed by a unit qualifier and the quantity

Package 53489-0176-01. 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 Mar 16, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072637

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 072637
Product	Strength	Form · route	Labeler	Product NDC
albuterol sulfate	Albuterol sulfate 4 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	53489-177
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	American Health Packaging	68084-949