Prescription drug · ANDA
Alprazolam NDC 68788-8394
Alprazolam 1 mg/1 · Tablet · Oral · PreferredPharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8394-1 | 68788839401 | 100 TABLET in 1 BOTTLE (68788-8394-1)Marketed from Mar 1, 2023 | |
| 68788-8394-2 | 68788839402 | 20 TABLET in 1 BOTTLE (68788-8394-2)Marketed from Mar 1, 2023 | |
| 68788-8394-3 | 68788839403 | 30 TABLET in 1 BOTTLE (68788-8394-3)Marketed from Mar 1, 2023 | |
| 68788-8394-6 | 68788839406 | 60 TABLET in 1 BOTTLE (68788-8394-6)Marketed from Mar 1, 2023 | |
| 68788-8394-9 | 68788839409 | 90 TABLET in 1 BOTTLE (68788-8394-9)Marketed from Mar 1, 2023 |
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 203346
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 68788-8394_e63a8f38-e1a8-474c-bedb-abba635dcd95SPL ID e63a8f38-e1a8-474c-bedb-abba635dcd95SPL set ID dc130aae-4510-4de7-a750-4a144e88208dRxCUI 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
N468788839401followed by a unit qualifier and the quantityPackage 68788-8394-01. 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 is 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 203346
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 | TabletOral | Coupler LLC | 67046-0007 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2966 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2976 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-676 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Coupler LLC | 67046-0154 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0444 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-677 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-678 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-678 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-679 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Medsource Pharmaceuticals | 45865-257 |
| Alprazolam C-IV | Alprazolam 1 mg/1 | TabletOral | Direct_Rx | 72189-443 |
| Alprazolam C-IV | Alprazolam .5 mg/1 | TabletOral | Direct_Rx | 72189-442 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Direct_Rx | 72189-450 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | AvPAK | 50268-034 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | AvPAK | 50268-033 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | AvPAK | 50268-035 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1894 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-061 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0678 |
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