Prescription drug · NDA AUTHORIZED GENERIC
Albuterol Sulfate HFA (Albuterol sulfate) NDC 80425-0359
Albuterol sulfate 90 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0359-1 | 8042503590180425035901 | 1 INHALER in 1 CARTON (80425-0359-1) / 200 AEROSOL, METERED in 1 INHALERMarketed from Sep 7, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020983
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 80425-0359_2a996b2b-b5da-65e7-e063-6394a90adeedSPL ID 2a996b2b-b5da-65e7-e063-6394a90adeedSPL set ID 04c8a345-0a0d-5a01-e063-6294a90a40d2RxCUI 2123076UNII 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
N480425035901followed by a unit qualifier and the quantityPackage 80425-0359-01. 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)
Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2 ) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged …
Excerpt only. Read the full label for complete information.
About NDC 80425-0359
- What is NDC 80425-0359?
- 80425-0359 is the product NDC for Albuterol Sulfate HFA (albuterol sulfate), Albuterol sulfate 90 ug/1 aerosol, metered, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Albuterol Sulfate HFA (Albuterol sulfate).
- What is the active ingredient?
- Albuterol sulfate.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 HFA?
- 6 other product NDCs are listed under this name. See all Albuterol Sulfate HFA NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Albuterol Sulfate HFA products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Albuterol Sulfate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-3174 | 00093-3174-31 |
| Albuterol Sulfate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | NuCare Pharmaceuticals,Inc. | 68071-4940 | 68071-4940-02 |
| Albuterol Sulfate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Proficient Rx LP | 71205-211 | 71205-0211-85 |
| Albuterol Sulfate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Asclemed USA, Inc. | 76420-088 | 76420-0088-01 |
| albuterol sulfate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-4137 | 50090-4137-00 |
| Albuterol Sulfate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Prasco Laboratories | 66993-019 | 66993-0019-68 |
Other NDCs under NDA 020983
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Albuterol Sulate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | NuCare Pharmaceuticals,Inc. | 68071-4777 |
| Albuterol Sulate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-2072 |
| Albuterol Sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | HF Acquisition Co LLC, DBA HealthFirst | 51662-1267 |
| albuterol sulfate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-4137 |
| Albuterol Sulfate HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Prasco Laboratories | 66993-019 |
| Ventolin HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0682 |
| Ventolin HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-1158 |
| Ventolin HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-1159 |
| Ventolin HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Proficient Rx LP | 63187-026 |
| Ventolin HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | NuCare Pharmaceuticals,Inc. | 68071-1670 |
| Ventolin HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | NuCare Pharmaceuticals,Inc. | 68071-1890 |
| Ventolin HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-1081 |
| Ventolin HFAalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-1237 |