Prescription drug · ANDA
Alprazolam NDC 80425-0100
Alprazolam 1 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0100-1 | 80425010001 | 30 TABLET in 1 BOTTLE (80425-0100-1)Marketed from Jul 11, 2024 | |
| 80425-0100-2 | 80425010002 | 60 TABLET in 1 BOTTLE (80425-0100-2)Marketed from Dec 25, 1995 |
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)
- Alprazolam
- Generic name (nonproprietary)
- alprazolam
- Active ingredients
- Alprazolam — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074112
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 80425-0100_1cfab3cb-1866-f860-e063-6294a90a464dSPL ID 1cfab3cb-1866-f860-e063-6294a90a464dSPL set ID b39e2bc8-b691-0f4e-e053-2995a90a00fdRxCUI 197321UNII YU55MQ3IZY
- Pharmacologic class
- Benzodiazepine
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
N480425010001followed by a unit qualifier and the quantityPackage 80425-0100-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1. Indications and Usage Alprazolam tablets are indicated for the: •acute treatment of generalized anxiety disorder (GAD) in adults. •treatment of panic disorder (PD), with or without agoraphobia in adults.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074112
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 |
|---|---|---|---|---|
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Proficient Rx LP | 63187-916 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-734 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-2896 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Proficient Rx LP | 63187-225 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | A-S Medication Solutions | 50090-1864 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Sandoz Inc | 0781-1061 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Sandoz Inc | 0781-1077 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0284 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Sandoz Inc | 0781-1079 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Proficient Rx LP | 63187-443 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-609 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-696 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4137 |