Prescription drug · ANDA
Alprazolam NDC 65162-809
Alprazolam .5 mg/1 · Tablet, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-809-03 | 65162080903 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-03)Marketed from Dec 3, 2009 | |
| 65162-809-06 | 65162080906 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-06)Marketed from Dec 3, 2009 | |
| 65162-809-50 | 65162080950 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-50)Marketed from Dec 3, 2009 |
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 — .5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078387
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 65162-809_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91SPL ID 4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91SPL set ID 259387c1-e374-4bc2-9510-5f7f2c60d1a5RxCUI 433798, 433799, 433800, 433801UNII YU55MQ3IZYUPC 0365162809503, 0365162810509, 0365162813500, 0365162809039, 0365162810035, 0365162813036, 0365162812039, 0365162812503
- 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
N465162080903followed by a unit qualifier and the quantityPackage 65162-0809-03. 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 078387
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 3 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-813 |
| Alprazolam | Alprazolam 1 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-810 |
| Alprazolam | Alprazolam 2 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-812 |