Prescription drug · ANDA
Alprazolam NDC 80425-0110
Alprazolam 1 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0110-2 | 80425011002 | 60 TABLET in 1 BOTTLE (80425-0110-2)Marketed from Oct 1, 1993 |
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
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074342
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 80425-0110_2a99a7f4-89df-19db-e063-6294a90a90daSPL ID 2a99a7f4-89df-19db-e063-6294a90a90daSPL set ID b4cd647f-1ba3-334e-e053-2995a90af352RxCUI 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
N480425011002followed by a unit qualifier and the quantityPackage 80425-0110-02. 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)
Indications and Usage Section INDICATIONS AND USAGE Anxiety Disorders Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days t…
Excerpt only. Read the full label for complete information.
About NDC 80425-0110
- What is NDC 80425-0110?
- 80425-0110 is the product NDC for Alprazolam, Alprazolam 1 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, 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?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?
- 120 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 1 mg/1 | TabletOral | AvPAK | 50268-035 | 50268-0035-15 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | AvPAK | 50268-034 | 50268-0034-15 |
| 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 074342
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 .25 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2027 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2029 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2039 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5078 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2220 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2292 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0849 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2133 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-112 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-113 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-313 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-328 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0099 |