Albuterol Sulfate HFA (albuterol sulfate) NDC 76420-088

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-088Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0088Add 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
76420-088-01	76420008801	1 INHALER in 1 CARTON (76420-088-01) / 200 AEROSOL, METERED in 1 INHALERMarketed from Oct 13, 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 Sulfate HFASuffix: HFA
Generic name (nonproprietary): albuterol sulfate
Active ingredients: Albuterol sulfate — 90 ug/1
Dosage form: Aerosol, Metered
Route: Respiratory (Inhalation)
Labeler: Asclemed USA, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021457
Marketing start: Jan 16, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 76420-088_0cdb4881-c3c2-9edf-e063-6394a90a5cacSPL ID 0cdb4881-c3c2-9edf-e063-6394a90a5cacSPL set ID a69489f7-4ffb-4cd1-b2d2-002f48e84f51RxCUI 2123072UNII 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 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

N476420008801 followed by a unit qualifier and the quantity

Package 76420-0088-01. 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 19, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Albuterol Sulfate HFA Inhalation Aerosol is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2 ) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021457

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

FDA NDC Directory listings under NDA 021457
Product	Strength	Form · route	Labeler	Product NDC
Albuterol Sulfate HFAalbuterol sulfate	Albuterol sulfate 90 ug/1	Aerosol, MeteredRespiratory (Inhalation)	Teva Pharmaceuticals USA, Inc.	0093-3174
Albuterol Sulfate HFAalbuterol sulfate	Albuterol sulfate 90 ug/1	Aerosol, MeteredRespiratory (Inhalation)	Proficient Rx LP	71205-211
Albuterol Sulfate HFAalbuterol sulfate	Albuterol sulfate 90 ug/1	Aerosol, MeteredRespiratory (Inhalation)	NuCare Pharmaceuticals,Inc.	68071-4940