Prescription drug · ANDA
Alprazolam NDC 76420-653
Alprazolam 2 mg/1 · Tablet, Extended release · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-653-30 | 76420065330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-30)Marketed from Jan 5, 2024 | |
| 76420-653-60 | 76420065360 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-60)Marketed from Jan 5, 2024 | |
| 76420-653-90 | 76420065390 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-90)Marketed from Jan 5, 2024 |
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)
- Alprazolam
- Generic name (nonproprietary)
- alprazolam
- Active ingredients
- Alprazolam — 2 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090871
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 76420-653_0e42e402-85e4-30a1-e063-6394a90a142cSPL ID 0e42e402-85e4-30a1-e063-6394a90a142cSPL set ID 5d839a8b-0f45-42bf-acc1-2bd28f948e53RxCUI 433798, 433799, 433800, 433801UNII 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
N476420065330followed by a unit qualifier and the quantityPackage 76420-0653-30. 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)
Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam extended-release tablets are a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090871
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 1 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-651 |
| Alprazolam | Alprazolam .5 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-652 |
| Alprazolam | Alprazolam 3 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-654 |
| Alprazolam | Alprazolam 1 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1839 |
| Alprazolam | Alprazolam 2 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 65862-456 |
| Alprazolam | Alprazolam .5 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 65862-454 |
| Alprazolam | Alprazolam 1 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 65862-455 |
| Alprazolam | Alprazolam 3 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 65862-457 |
| Alprazolam | Alprazolam 1 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-445 |
| Alprazolam | Alprazolam .5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1669 |
| Alprazolam | Alprazolam .5 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-518 |