Prescription drug · ANDA
Albuterol Sulfate Inhalation Solution, 0.5% (Albuterol sulfate) NDC 76204-027
Albuterol sulfate 2.5 mg/.5mL · Solution · Respiratory (Inhalation) · Ritedose Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76204-027-01 | 76204002701 | 30 POUCH in 1 CARTON (76204-027-01) / 1 VIAL in 1 POUCH (76204-027-11) / .5 mL in 1 VIALMarketed from Mar 24, 2025 |
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, 0.5%
- Generic name (nonproprietary)
- albuterol sulfate
- Active ingredients
- Albuterol sulfate — 2.5 mg/.5mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Ritedose Pharmaceuticals, LLCNDC labeler code 76204
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218386
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 76204-027_4e7f86ab-55bc-c123-e063-6394a90abd8dSPL ID 4e7f86ab-55bc-c123-e063-6394a90abd8dSPL set ID fdb4ac5a-bf0d-4896-89f7-1828c081b79eRxCUI 245314UNII 021SEF3731UPC 0376204027113, 0376204027014
- 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
N476204002701followed by a unit qualifier and the quantityPackage 76204-0027-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.
Excerpt only. Read the full label for complete information.
About NDC 76204-027
- What is NDC 76204-027?
- 76204-027 is the product NDC for Albuterol Sulfate Inhalation Solution, 0.5%, Albuterol sulfate 2.5 mg/.5mL solution, listed with the FDA by Ritedose Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Albuterol Sulfate Inhalation Solution, 0.5% (Albuterol Sulfate).
- What is the active ingredient?
- Albuterol sulfate.
- Who is the labeler?
- Ritedose Pharmaceuticals, LLC, NDC labeler code 76204. 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 Sulfate Inhalation Solution, 0.5%?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.