Prescription drug · ANDA
Alprazolam NDC 63187-518
Alprazolam .5 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-518-30 | 63187051830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-518-30)Marketed from Dec 1, 2018 | |
| 63187-518-60 | 63187051860 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-518-60)Marketed from Dec 1, 2018 | |
| 63187-518-90 | 63187051890 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-518-90)Marketed from Dec 1, 2018 |
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, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090871
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 63187-518_b2f8ddeb-2879-48e7-a026-1de3bc87610dSPL ID b2f8ddeb-2879-48e7-a026-1de3bc87610dSPL set ID 969acb29-3b5c-47ed-8f7d-a960a24e72e3RxCUI 433798UNII 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
N463187051830followed by a unit qualifier and the quantityPackage 63187-0518-30. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Alprazolam extended-release tablets USP are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extended-release tablets USP conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL EFFICACY TRIALS ). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; …
Excerpt only. Read the full label for complete information.
About NDC 63187-518
- What is NDC 63187-518?
- 63187-518 is the product NDC for Alprazolam, Alprazolam .5 mg/1 tablet, extended release, listed with the FDA by Proficient Rx LP. 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?
- Proficient Rx LP, NDC labeler code 63187. 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 090871
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 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-445 |
| Alprazolam | Alprazolam 1 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 65862-455 |
| Alprazolam | Alprazolam .5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1669 |
| Alprazolam | Alprazolam 1 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1839 |
| Alprazolam | Alprazolam 1 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-651 |
| Alprazolam | Alprazolam .5 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-652 |
| Alprazolam | Alprazolam 2 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-653 |
| Alprazolam | Alprazolam 3 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-654 |