Prescription drug · ANDA
Alprazolam NDC 71335-1669
Alprazolam .5 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1669-1 | 71335166901 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-1)Marketed from May 12, 2021 | |
| 71335-1669-2 | 71335166902 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-2)Marketed from Feb 14, 2022 | |
| 71335-1669-3 | 71335166903 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-3)Marketed from Jul 21, 2020 | |
| 71335-1669-4 | 71335166904 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-4)Marketed from Feb 14, 2022 | |
| 71335-1669-5 | 71335166905 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1669-5)Marketed from Feb 14, 2022 |
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 — .5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-1669_1a903918-4b82-41a8-89c1-2dfc56c1d423SPL ID 1a903918-4b82-41a8-89c1-2dfc56c1d423SPL set ID 0dce8232-0b0e-4f81-af95-36e6febdb550RxCUI 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
N471335166901followed by a unit qualifier and the quantityPackage 71335-1669-01. 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 extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam extended-release tablets are a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71335-1669
- What is NDC 71335-1669?
- 71335-1669 is the product NDC for Alprazolam, Alprazolam .5 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 5 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 .5 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-518 |
| Alprazolam | Alprazolam 1 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 65862-455 |
| 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 |