Prescription drug · ANDA
Alprazolam NDC 0781-1061
Alprazolam .25 mg/1 · Tablet · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-1061-01 | 00781106101 | 100 TABLET in 1 BOTTLE (0781-1061-01)Marketed from Dec 29, 1995 | |
| 0781-1061-05 | 00781106105 | 500 TABLET in 1 BOTTLE (0781-1061-05)Marketed from Dec 29, 1995 | |
| 0781-1061-10 | 00781106110 | 1000 TABLET in 1 BOTTLE (0781-1061-10)Marketed from Dec 29, 1995 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- 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 0781-1061_4c8c7366-aa3b-4124-9d64-67fb0ead6e15SPL ID 4c8c7366-aa3b-4124-9d64-67fb0ead6e15SPL set ID d9b0e228-17cf-40d7-b62e-5050311c571cRxCUI 197321, 197322, 308047, 308048UNII 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
N400781106101followed by a unit qualifier and the quantityPackage 00781-1061-01. 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.
About NDC 0781-1061
- What is NDC 0781-1061?
- 0781-1061 is the product NDC for Alprazolam, Alprazolam .25 mg/1 tablet, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alprazolam.
- What is the active ingredient?
- Alprazolam.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alprazolam?
- 114 other product NDCs are listed under this name. See all Alprazolam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alprazolam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Coupler LLC | 67046-0007 | 67046-0007-03 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Coupler LLC | 67046-0154 | 67046-0154-03 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | AvPAK | 50268-033 | 50268-0033-15 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | AvPAK | 50268-034 | 50268-0034-15 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | AvPAK | 50268-035 | 50268-0035-15 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0444 | 80425-0444-0180425-0444-02 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-061 | 82868-0061-30 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4137 | 70518-4137-00 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | American Health Packaging | 60687-388 | 60687-0388-01 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | American Health Packaging | 60687-377 | 60687-0377-01 |
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 .5 mg/1 | TabletOral | Sandoz Inc | 0781-1077 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Sandoz Inc | 0781-1079 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-609 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | A-S Medication Solutions | 50090-1864 |
| 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 1 mg/1 | TabletOral | Proficient Rx LP | 63187-443 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Proficient Rx LP | 63187-916 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4137 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-696 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-734 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0100 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0284 |