Albuterol NDC 59651-333

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-333Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0333Add 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	Copy
59651-333-01	59651033301	100 TABLET in 1 BOTTLE (59651-333-01)Marketed from May 14, 2020
59651-333-05	59651033305	500 TABLET in 1 BOTTLE (59651-333-05)Marketed from May 14, 2020

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
Generic name (nonproprietary): albuterol
Active ingredients: Albuterol sulfate — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213657
Marketing start: May 14, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 59651-333_f89dffb1-5c4b-48aa-90b4-74043fc9b690SPL ID f89dffb1-5c4b-48aa-90b4-74043fc9b690SPL set ID ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6RxCUI 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

N459651033301 followed by a unit qualifier and the quantity

Package 59651-0333-01. 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 Dec 15, 2022.

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 213657

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

FDA NDC Directory listings under ANDA 213657
Product	Strength	Form · route	Labeler	Product NDC
Albuterol	Albuterol sulfate 4 mg/1	TabletOral	Aurobindo Pharma Limited	59651-334