What is NDC 59651-334?

59651-334 is the product NDC for Albuterol, Albuterol sulfate 4 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Albuterol NDC 59651-334 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-334Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0334Add 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
59651-334-01	5965103340159651033401	100 TABLET in 1 BOTTLE (59651-334-01)Marketed from May 14, 2020
59651-334-05	5965103340559651033405	500 TABLET in 1 BOTTLE (59651-334-05)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 — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213657
Marketing start: May 14, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 59651-334_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

N459651033401 followed by a unit qualifier and the quantity

Package 59651-0334-01. 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)

About NDC 59651-334

What is NDC 59651-334?: 59651-334 is the product NDC for Albuterol, Albuterol sulfate 4 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Albuterol.
What is the active ingredient?: Albuterol sulfate.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 59651. 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?: 15 other product NDCs are listed under this name. See all Albuterol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Albuterol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Albuterolalbuterol sulfate	Albuterol sulfate 90 ug/1	Aerosol, MeteredRespiratory (Inhalation)	Cipla USA Inc.	69097-021	69097-0021-60
Albuterol	Albuterol sulfate .63 mg/3mL	SolutionRespiratory (Inhalation)	Mylan Pharmaceuticals Inc.	0378-7057	00378-7057-52
Albuterol	Albuterol sulfate 1.25 mg/3mL	SolutionRespiratory (Inhalation)	Mylan Pharmaceuticals Inc.	0378-7058	00378-7058-52
Albuterol	Albuterol sulfate 2 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	70710-1061	70710-1061-01
Albuterol	Albuterol sulfate 4 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	70710-1062	70710-1062-0170710-1062-05
Albuterol	Albuterol sulfate 2 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1511	70771-1511-01
Albuterol	Albuterol sulfate 4 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1512	70771-1512-0170771-1512-05
Albuterol	Albuterol sulfate 2 mg/1	TabletOral	Aurobindo Pharma Limited	59651-333	59651-0333-0159651-0333-05
Albuterol	Albuterol sulfate 4 mg/1	TabletOral	Bryant Ranch Prepack	63629-2611	63629-2611-0163629-2611-0263629-2611-03
Albuterol	Albuterol sulfate 2 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-442	64980-0442-0164980-0442-50

All 16 Albuterol NDCs

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 2 mg/1	TabletOral	Aurobindo Pharma Limited	59651-333