Prescription drug · ANDA
Albuterol NDC 71205-899
Albuterol sulfate 4 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-899-00 | 7120508990071205089900 | 100 TABLET in 1 BOTTLE (71205-899-00)Marketed from Jul 30, 2021 | |
| 71205-899-11 | 7120508991171205089911 | 1000 TABLET in 1 BOTTLE (71205-899-11)Marketed from Jul 30, 2021 | |
| 71205-899-30 | 7120508993071205089930 | 30 TABLET in 1 BOTTLE (71205-899-30)Marketed from Jul 30, 2021 | |
| 71205-899-55 | 7120508995571205089955 | 500 TABLET in 1 BOTTLE (71205-899-55)Marketed from Jul 30, 2021 | |
| 71205-899-60 | 7120508996071205089960 | 60 TABLET in 1 BOTTLE (71205-899-60)Marketed from Jul 30, 2021 | |
| 71205-899-90 | 7120508999071205089990 | 90 TABLET in 1 BOTTLE (71205-899-90)Marketed from Jul 30, 2021 |
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
- Generic name (nonproprietary)
- albuterol
- Active ingredients
- Albuterol sulfate — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207046
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 71205-899_f5ac6375-7f17-4d27-b13a-b44e73281838SPL ID f5ac6375-7f17-4d27-b13a-b44e73281838SPL set ID 895dff1c-d21c-4470-b021-a5b68364c1ecRxCUI 197316, 197318UNII 021SEF3731UPC 0371205898304, 0371205899301
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471205089900followed by a unit qualifier and the quantityPackage 71205-0899-00. 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 & USAGE Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
Excerpt only. Read the full label for complete information.
About NDC 71205-899
- What is NDC 71205-899?
- 71205-899 is the product NDC for Albuterol, Albuterol sulfate 4 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Albuterol.
- What is the active ingredient?
- Albuterol sulfate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. 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?
- 15 other product NDCs are listed under this name. See all Albuterol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Albuterol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Albuterolalbuterol sulfate | Albuterol sulfate 90 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Cipla USA Inc. | 69097-021 | 69097-0021-60 |
| Albuterol | Albuterol sulfate .63 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-7057 | 00378-7057-52 |
| Albuterol | Albuterol sulfate 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-7058 | 00378-7058-52 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1061 | 70710-1061-01 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1062 | 70710-1062-0170710-1062-05 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1511 | 70771-1511-01 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1512 | 70771-1512-0170771-1512-05 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-333 | 59651-0333-0159651-0333-05 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-334 | 59651-0334-0159651-0334-05 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2611 | 63629-2611-0163629-2611-0263629-2611-03 |
Other NDCs under ANDA 207046
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 | Albuterol sulfate 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2611 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-442 |
| Albuterol | Albuterol sulfate 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-443 |
| Albuterol | Albuterol sulfate 2 mg/1 | TabletOral | Proficient Rx LP | 71205-898 |