Prescription drug · NDA
Albuterol Sulfate HFA (Albuterol sulfate) NDC 68071-4940
Albuterol sulfate 90 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4940-2 | 6807149400268071494002 | 200 AEROSOL, METERED in 1 BOX (68071-4940-2)Marketed from Jun 25, 2019 |
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
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021457
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 68071-4940_1b2e1fc4-f5f8-9895-e063-6394a90ad067SPL ID 1b2e1fc4-f5f8-9895-e063-6394a90ad067SPL set ID 8c278b6f-d32b-b750-e053-2995a90ad7e9RxCUI 2123072UNII 021SEF3731UPC 0368071494020
- 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
N468071494002followed by a unit qualifier and the quantityPackage 68071-4940-02. 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 . 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.
About NDC 68071-4940
- What is NDC 68071-4940?
- 68071-4940 is the product NDC for Albuterol Sulfate HFA (albuterol sulfate), Albuterol sulfate 90 ug/1 aerosol, metered, listed with the FDA by NuCare Pharmaceuticals,Inc.. 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?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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) | Advanced Rx of Tennessee, LLC | 80425-0359 | 80425-0359-01 |
| 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) | 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 021457
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 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) | Asclemed USA, Inc. | 76420-088 |