Alprazolam
- Product NDC
- 65862-677
- Requested package NDC
- 65862-677-01
- 11-digit product format
- 658620677
- Labeler code
- 65862
- Product ID
- 65862-677_7527aeb7-8912-404d-afb7-8c692c84422b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203346
- Marketing category
- ANDA
- Marketing start
- 2015-07-31
- Substance
- ALPRAZOLAM
- Active strength
- .5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203346-001 | ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | |
| A203346-002 | ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | |
| A203346-003 | ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | |
| A203346-004 | ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203346-001 | AB |
| A203346-002 | AB |
| A203346-003 | AB |
| A203346-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203346-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203346-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203346-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203346-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203346-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203346-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203346-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203346-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203346-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203346-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203346-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203346-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203346-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203346-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203346-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203346-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alprazolam
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALPRAZOLAM | .5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| YU55MQ3IZY | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d2fd0b3e-9b78-44d0-82a6-96d6c6238750 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 2ffbe5ef-58ff-88b9-e291-045e0f861f4f | Product name | 4 | 20180827 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 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 |
|---|---|---|---|---|---|---|
| 65862-677-01 | Alprazolam | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 65862-677-05 | Alprazolam | 500 in 1 BOTTLE | TABLET | 500 | 10 | |
| 65862-677-99 | Alprazolam | 1000 in 1 BOTTLE | TABLET | 1000 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-677-01 | EA - Each | 65862-677 | 7775b6f8-0daa-4696-adc2-6505f652a092 | 1 | 2020-04-20 |
| 65862-677-05 | EA - Each | 65862-677 | 526a5db5-b87b-47d8-91db-7eeb76564793 | 1 | 2020-04-20 |
| 65862-677-99 | EA - Each | 65862-677 | acd099b2-6afb-436b-82a7-23357bbf04df | 1 | 2018-03-08 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alprazolam | ALPRAZOLAM | NuCare Pharmaceuticals, Inc. | 315b8cf2-01a0-3f7d-e063-6394a90a39b5 | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Direct_Rx | f77cfdd0-847d-4edd-e053-6394a90a91b7 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | NuCare Pharmaceuticals,Inc. | 02840ea6-e4a0-96a0-e063-6394a90a19ae | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | American Health Packaging | ea95d182-453b-4c43-8402-d65c488d55f2 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Advanced Rx of Tennessee, LLC | 26f8b63c-6dad-8fac-e063-6394a90a5435 | 2024-11-06 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | NuCare Pharmaceuticals,Inc. | f7e63d96-2310-4ab1-e053-6294a90a86fc | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Medsource Pharmaceuticals | 14960c0c-555f-acc1-e063-6394a90a232a | 2024-03-26 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | NuCare Pharmaceuticals,Inc. | f9903822-642d-e364-e053-6394a90a22d8 | 2024-03-12 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | 68e6ef8c-4104-4636-9719-6aa386c892d9 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-677-01 | 65862067701 | 100 TABLET in 1 BOTTLE (65862-677-01) | 100 tablet | 2015-07-31 | 0000-00-00 | No | No | Current |