Prescription drug · ANDA
Alprazolam NDC 55289-523
Alprazolam 2 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-523-01 | 55289052301 | 100 TABLET in 1 BOTTLE, PLASTIC (55289-523-01)Marketed from Mar 4, 2016 | |
| 55289-523-30 | 55289052330 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-523-30)Marketed from Mar 4, 2016 | |
| 55289-523-40 | 55289052340 | 40 TABLET in 1 BOTTLE, PLASTIC (55289-523-40)Marketed from Mar 4, 2016 | |
| 55289-523-60 | 55289052360 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-523-60)Marketed from Mar 4, 2016 | |
| 55289-523-90 | 55289052390 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-523-90)Marketed from Mar 4, 2016 |
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
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074909
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 55289-523_2abee2c1-1fa5-af2e-e063-6294a90a6afbSPL ID 2abee2c1-1fa5-af2e-e063-6294a90a6afbSPL set ID 7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3RxCUI 197322UNII 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
N455289052301followed by a unit qualifier and the quantityPackage 55289-0523-01. 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)
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. Alprazolam tablets are a benzodiazepine indicated for the: Acute treatment of generalized anxiety disorder in adults. ( 1 ) Treatment of panic disorder with or without agoraphobia in adults. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074909
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 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0920 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Proficient Rx LP | 63187-444 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Sandoz Inc | 0781-1089 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-2819 |