Prescription drug · ANDA
Alprazolam NDC 72789-313
Alprazolam .5 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-313-06 | 72789031306 | 6 TABLET in 1 BOTTLE, PLASTIC (72789-313-06)Marketed from Jun 18, 2024 | |
| 72789-313-30 | 72789031330 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-313-30)Marketed from Jul 31, 2023 | |
| 72789-313-60 | 72789031360 | 60 TABLET in 1 BOTTLE, PLASTIC (72789-313-60)Marketed from May 9, 2023 | |
| 72789-313-90 | 72789031390 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-313-90)Marketed from Mar 16, 2023 |
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
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 72789-313_40bb1fd8-e70f-47eb-e063-6394a90a74a8SPL ID 40bb1fd8-e70f-47eb-e063-6394a90a74a8SPL set ID 5040e1ed-32d6-4757-a0ee-b8240f3e7cf5RxCUI 308048UNII YU55MQ3IZYUPC 0372789313900
- 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
N472789031306followed by a unit qualifier and the quantityPackage 72789-0313-06. 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 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 .5 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2029 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2031 |
| Alprazolam | Alprazolam 2 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2039 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-328 |
| 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 .25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2292 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2220 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5078 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0099 |
| Alprazolam | Alprazolam 1 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0110 |
| Alprazolam | Alprazolam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0849 |
| Alprazolam | Alprazolam .25 mg/1 | TabletOral | Actavis Pharma, Inc. | 0228-2027 |