Alprazolam
- Product NDC
- 0228-4022
- 11-digit product format
- 002284022
- Labeler code
- 0228
- Product ID
- 0228-4022_38c5b407-25a1-48f5-960e-87ef637b644c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA078561
- Marketing category
- ANDA
- Marketing start
- 2010-03-17
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078561-001 | ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | |
| A078561-002 | ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | |
| A078561-003 | ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | |
| A078561-004 | ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078561-001 | AB |
| A078561-002 | AB |
| A078561-003 | AB |
| A078561-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078561-001 | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078561-002 | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078561-003 | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078561-004 | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-03-16 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078561-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078561-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078561-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078561-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078561-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078561-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078561-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078561-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078561-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078561-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078561-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078561-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078561-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078561-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078561-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078561-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078561-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078561-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078561-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078561-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078561-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078561-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078561-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078561-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078561-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078561-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078561-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078561-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078561-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078561-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078561-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078561-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078561-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078561-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078561-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078561-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078561-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078561-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078561-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078561-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alprazolam
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 0228-4022-11 | Alprazolam | 100 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 100 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0228-4022-11 | EA - Each | 0228-4022 | 43f04cf3-5c6e-470d-87a8-076d77823f4b | 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 | ALPRAZOLAM | Actavis Pharma, Inc. | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | 078561 ANDA078561 0228-4022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485413 | ALPRAZolam 0.25 MG Disintegrating Oral Tablet | PSN | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 24 |
| 485415 | ALPRAZolam 0.5 MG Disintegrating Oral Tablet | PSN | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 24 |
| 485414 | ALPRAZolam 1 MG Disintegrating Oral Tablet | PSN | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 24 |
| 485416 | ALPRAZolam 2 MG Disintegrating Oral Tablet | PSN | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 24 |
| 485413 | alprazolam 0.25 MG Disintegrating Oral Tablet | SCD | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 24 |
| 485415 | alprazolam 0.5 MG Disintegrating Oral Tablet | SCD | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 24 |
| 485414 | alprazolam 1 MG Disintegrating Oral Tablet | SCD | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 24 |
| 485416 | alprazolam 2 MG Disintegrating Oral Tablet | SCD | 5ceed721-2e65-4c81-bd84-f110b1ac9d2e | 24 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0228-4022-11 | 00228402211 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4022-11) | 2010-03-17 | 0000-00-00 | No | No | Current |