Alprazolam
- Product NDC
- 65162-809
- 11-digit product format
- 651620809
- Labeler code
- 65162
- Product ID
- 65162-809_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA078387
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- Substance
- ALPRAZOLAM
- Active strength
- .5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alprazolam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALPRAZOLAM | .5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | YU55MQ3IZY |
| Rxcui | 433798, 433799, 433800, 433801 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2ffbe5ef-58ff-88b9-e291-045e0f861f4f | Product name | 4 | 20180827 |
| 1f9e6d58-49d3-d9c1-e570-4bb0466a2c0b | Product name | 1 | 20140508 |
| a1a11520-f3e2-68fa-8bd9-e80b271ef797 | Product name | 1 | 20140508 |
| d153678e-a3c8-bad8-cfe0-385656dde0e7 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-809-03 | Alprazolam | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 15 | |
| 65162-809-06 | Alprazolam | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 15 | |
| 65162-809-50 | Alprazolam | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 15 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 433798 | ALPRAZolam 0.5 MG 24HR Extended Release Oral Tablet | PSN | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433800 | ALPRAZolam 1 MG 24HR Extended Release Oral Tablet | PSN | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433799 | ALPRAZolam 2 MG 24HR Extended Release Oral Tablet | PSN | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433801 | ALPRAZolam 3 MG 24HR Extended Release Oral Tablet | PSN | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433798 | 24 HR alprazolam 0.5 MG Extended Release Oral Tablet | SCD | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433800 | 24 HR alprazolam 1 MG Extended Release Oral Tablet | SCD | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433799 | 24 HR alprazolam 2 MG Extended Release Oral Tablet | SCD | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433801 | 24 HR alprazolam 3 MG Extended Release Oral Tablet | SCD | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433798 | alprazolam 0.5 MG 24 HR Extended Release Oral Tablet | SY | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433800 | alprazolam 1 MG 24 HR Extended Release Oral Tablet | SY | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433799 | alprazolam 2 MG 24 HR Extended Release Oral Tablet | SY | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433801 | alprazolam 3 MG 24 HR Extended Release Oral Tablet | SY | 259387c1-e374-4bc2-9510-5f7f2c60d1a5 | 15 |
| 433798 | ALPRAZolam 0.5 MG 24HR Extended Release Oral Tablet | PSN | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
| 433800 | ALPRAZolam 1 MG 24HR Extended Release Oral Tablet | PSN | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
| 433799 | ALPRAZolam 2 MG 24HR Extended Release Oral Tablet | PSN | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
| 433798 | 24 HR alprazolam 0.5 MG Extended Release Oral Tablet | SCD | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
| 433800 | 24 HR alprazolam 1 MG Extended Release Oral Tablet | SCD | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
| 433799 | 24 HR alprazolam 2 MG Extended Release Oral Tablet | SCD | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
| 433798 | alprazolam 0.5 MG 24 HR Extended Release Oral Tablet | SY | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
| 433800 | alprazolam 1 MG 24 HR Extended Release Oral Tablet | SY | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
| 433799 | alprazolam 2 MG 24 HR Extended Release Oral Tablet | SY | 98cc444a-2c39-4410-8020-aded0a8deb81 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65162-809-03 | 65162080903 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-03) | 2009-12-03 | 0000-00-00 | No | No | Current |
| 65162-809-06 | 65162080906 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-06) | 2009-12-03 | 0000-00-00 | No | No | Current |
| 65162-809-50 | 65162080950 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-50) | 2009-12-03 | 0000-00-00 | No | No | Current |