Albuterol Sulfate Inhalation Solution NDC 76204-011

NDC codes

FDA NDC Directory

Product NDC (as listed)76204-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76204-0011Add 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
76204-011-01	76204001101	30 POUCH in 1 CARTON (76204-011-01) / 1 VIAL in 1 POUCH (76204-011-11) / 3 mL in 1 VIALMarketed from Jan 4, 2022
76204-011-55	76204001155	25 POUCH in 1 CARTON (76204-011-55) / 5 VIAL in 1 POUCH (76204-011-05) / 3 mL in 1 VIALMarketed from Jan 4, 2022

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 Inhalation Solution
Generic name (nonproprietary): albuterol sulfate
Active ingredients: Albuterol sulfate — 1.25 mg/3mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Ritedose Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214531
Marketing start: Jan 4, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 76204-011_4ffd498d-4575-dd61-e063-6394a90a95d6SPL ID 4ffd498d-4575-dd61-e063-6394a90a95d6SPL set ID d4c532be-1f41-60d3-e053-2995a90a98beRxCUI 351136, 351137UNII 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

N476204001101 followed by a unit qualifier and the quantity

Package 76204-0011-01. 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 Apr 30, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Albuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (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 214531

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

FDA NDC Directory listings under ANDA 214531
Product	Strength	Form · route	Labeler	Product NDC
Albuterol	Albuterol sulfate .63 mg/3mL	SolutionRespiratory (Inhalation)	Mylan Pharmaceuticals Inc.	0378-7057
Albuterol	Albuterol sulfate 1.25 mg/3mL	SolutionRespiratory (Inhalation)	Mylan Pharmaceuticals Inc.	0378-7058
Albuterol Sulfate Inhalation Solutionalbuterol sulfate	Albuterol sulfate .63 mg/3mL	SolutionRespiratory (Inhalation)	Ritedose Pharmaceuticals, LLC	76204-010