Alprazolam
- Product NDC
- 0228-3086
- 11-digit product format
- 002283086
- Labeler code
- 0228
- Product ID
- 0228-3086_e89f9f55-9cd1-4b9d-b0a0-2d0480dd559c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA078056
- Marketing category
- ANDA
- Marketing start
- 2007-03-12
- Marketing end
- 2026-07-31
- Substance
- ALPRAZOLAM
- Active strength
- 3 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0228-3086 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 0228-3086 | 0228-3086-06 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078056-001 | ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | |
| A078056-002 | ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | |
| A078056-003 | ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | |
| A078056-004 | ALPRAZOLAM | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078056-001 | AB |
| A078056-002 | AB |
| A078056-003 | AB |
| A078056-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078056-001 | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078056-002 | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078056-003 | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078056-004 | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2007-02-13 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078056-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078056-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078056-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078056-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078056-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078056-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078056-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078056-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078056-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078056-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078056-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078056-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078056-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078056-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078056-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078056-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078056-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078056-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078056-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078056-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078056-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078056-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078056-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078056-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078056-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078056-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078056-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078056-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078056-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078056-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078056-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078056-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078056-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078056-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078056-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078056-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078056-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078056-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078056-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078056-004 | AB | 1 | d8e5a09893c0… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
| 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 |
|---|---|---|---|---|---|---|
| 0228-3086-06 | AlprazolamExtended Release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0228-3086-06 | EA - Each | 0228-3086 | b80b91f6-955a-4083-a637-c0218f1b763b | 1 | 2012-07-24 |
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 Extended Release | ALPRAZOLAM | Bryant Ranch Prepack | 29477df1-68aa-44b3-bf9e-80ecff6ce879 | 2024-05-17 | Boxed warning, Warnings, Adverse reactions | 078056 ANDA078056 |
| Alprazolam Extended Release | ALPRAZOLAM | Bryant Ranch Prepack | 4f6e4656-689f-46a6-a8ed-54ee55583357 | 2023-05-08 | Boxed warning, Warnings, Adverse reactions | 078056 ANDA078056 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 433798 | ALPRAZolam 0.5 MG 24HR Extended Release Oral Tablet | PSN | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433800 | ALPRAZolam 1 MG 24HR Extended Release Oral Tablet | PSN | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433799 | ALPRAZolam 2 MG 24HR Extended Release Oral Tablet | PSN | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433801 | ALPRAZolam 3 MG 24HR Extended Release Oral Tablet | PSN | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433798 | 24 HR alprazolam 0.5 MG Extended Release Oral Tablet | SCD | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433800 | 24 HR alprazolam 1 MG Extended Release Oral Tablet | SCD | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433799 | 24 HR alprazolam 2 MG Extended Release Oral Tablet | SCD | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433801 | 24 HR alprazolam 3 MG Extended Release Oral Tablet | SCD | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433798 | alprazolam 0.5 MG 24 HR Extended Release Oral Tablet | SY | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433800 | alprazolam 1 MG 24 HR Extended Release Oral Tablet | SY | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433799 | alprazolam 2 MG 24 HR Extended Release Oral Tablet | SY | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
| 433801 | alprazolam 3 MG 24 HR Extended Release Oral Tablet | SY | a64496be-bf43-4ba9-a4b1-bd632965c1a0 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0228-3086-06 | 00228308606 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3086-06) | 2007-03-12 | 2026-07-31 | No | No | Current |