Alprazolam
- Product NDC
- 64980-396
- Requested package NDC
- 64980-396-50
- 11-digit product format
- 649800396
- Labeler code
- 64980
- Product ID
- 64980-396_f69a9cd9-e516-4a6a-adba-29db5cee019c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA203346
- Marketing category
- ANDA
- Marketing start
- 2017-11-07
- Marketing end
- 0000-00-00
- Substance
- ALPRAZOLAM
- Active strength
- 0 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 64980-396 | 64980-396-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203346-001 | ALPRAZOLAM | 0.25MG | TABLET / ORAL | AB | 2015-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203346-002 | ALPRAZOLAM | 0.5MG | TABLET / ORAL | AB | 2015-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203346-003 | ALPRAZOLAM | 1MG | TABLET / ORAL | AB | 2015-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203346-004 | ALPRAZOLAM | 2MG | TABLET / ORAL | AB | 2015-07-31 | 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 | 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… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203346-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203346-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203346-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203346-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203346-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203346-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203346-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203346-004 | AB | 1 | d06236e962d9… |
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 | Clinical Solutions Wholesale, LLC | 0cf8b567-201b-44fa-8fd3-c74023aff44f | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | PD-Rx Pharmaceuticals, Inc. | 4203d3fe-916e-41af-9daf-f58f4fed6f9c | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | St. Mary's Medical Park Pharmacy | fc5fe795-6b41-aecf-e053-6394a90af562 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Bryant Ranch Prepack | 68d8b8d1-00a4-42c4-a796-90211fee1a6d | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Coupler LLC | 5111e57d-8920-6861-e063-6294a90a2194 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | ASCLEMED USA INC. | 8d76a554-7ed1-4c93-a5ea-30898aec0aa1 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Coupler LLC | 509a8a86-d61c-3f05-e063-6394a90a52ca | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Bryant Ranch Prepack | 2bd0d4c6-0fde-46f2-bb13-da25d50427df | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Bryant Ranch Prepack | d8364af1-d23e-4cd7-9a81-077ae97a951a | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Bryant Ranch Prepack | 0e2644fa-8334-4209-a63d-2466b5ab55b4 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam C-IV | ALPRAZOLAM C-IV | Direct_Rx | f6dd8005-1d50-41bc-e053-6394a90ac45b | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Proficient Rx LP | c6795ed8-af28-41f4-b85b-48e1fe9d0369 | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | PreferredPharmaceuticals Inc. | dc130aae-4510-4de7-a750-4a144e88208d | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Preferred Pharmaceuticals Inc. | 73c1d1dc-ade2-4bb4-b109-83bd63acd15c | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Preferred Pharmaceuticals Inc. | 78682252-e448-4b20-b49d-27c2c70e4cb3 | 2026-02-18 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Northwind Health Company, LLC | 25174ee5-a86e-ab97-e063-6394a90acd87 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | Aurobindo Pharma Limited | d2fd0b3e-9b78-44d0-82a6-96d6c6238750 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | AvPAK | 3fa14fa4-45a7-6ef4-e063-6394a90a1dcd | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam C-IV | ALPRAZOLAM C-IV | Direct_Rx | f6dd0e94-4a79-769f-e053-6394a90a5ae6 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
| Alprazolam | ALPRAZOLAM | NuCare Pharmaceuticals, Inc. | 315b5782-969a-4324-e063-6394a90acf37 | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 203346 ANDA203346 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64980-396-50 | 64980039650 | 500 TABLET in 1 BOTTLE (64980-396-50) | 500 tablet | 2017-11-07 | 0000-00-00 | No | No | Current |