clonidine hydrochloride
- Product NDC
- 62332-169
- 11-digit product format
- 623320169
- Labeler code
- 62332
- Product ID
- 62332-169_f3d64f9f-6bfb-48e8-aed1-5623415005ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clonidine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA091368
- Marketing category
- ANDA
- Marketing start
- 2026-09-22
- Substance
- CLONIDINE HYDROCHLORIDE
- Active strength
- .05 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| A091368-001 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | |
| A091368-002 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | |
| A091368-003 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091368-001 | AB |
| A091368-002 | AB |
| A091368-003 | 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 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091368-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091368-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091368-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091368-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091368-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091368-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091368-001 | AB | 1 | 301d65b070ca… |
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
- clonidine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLONIDINE HYDROCHLORIDE | .05 mg/1 |
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 |
|---|---|---|---|---|---|---|
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Coupler LLC | 58772b44-dec0-7001-e063-6394a90ac40e | 2026-08-07 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Redpharm Drug | 53df40e7-dd2b-d40e-e063-6394a90a21c4 | 2026-07-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | REMEDYREPACK INC. | 574640a5-829d-4e9d-be32-832a48cbd8dd | 2026-07-02 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | REMEDYREPACK INC. | 2a183d05-5be7-43e9-a084-700ec05d01e9 | 2026-07-02 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 666e757e-9b43-2e40-e053-2991aa0a59a2 | 2026-05-05 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d6 | 2026-03-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 56a80e79-9cfe-4361-a90a-9245632efa05 | 2026-03-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 770b56aa-fcf3-4327-98d1-d87e5a037234 | 2026-03-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | VERITYRX, LLC | 42788adf-a54d-3545-e063-6394a90a8c69 | 2025-10-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 746dcdfd-7dfb-4a29-e053-2991aa0a8a4c | 2025-05-07 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | 100a31f2-9a8e-4245-a09c-05583c3244c3 | 2025-03-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | 1c13555e-acfc-4a3a-93cd-e6f012f36c61 | 2025-03-28 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5366a055-47fd-41eb-81d8-ffb3be1dc38c | 2025-02-05 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 61b56917-1442-4068-86d8-0e5a5a59e612 | 2025-01-23 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | A-S Medication Solutions | 329382fb-ccf8-488d-a0b2-68ff959a0846 | 2024-12-20 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | A-S Medication Solutions | aecd05bf-e7ba-4cab-9494-4ce3bbd1aa99 | 2024-12-20 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | be6c29cd-1692-4dd3-868e-7efcb3a85056 | 2024-08-23 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a9de8b29-5cd2-a49d-e053-2995a90a4f0e | 2024-07-17 | Warnings, Adverse reactions | 091368 ANDA091368 |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | DirectRX | 2823a922-3217-6062-e054-00144ff88e88 | 2024-01-09 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 88a8db46-0fc9-48cd-b7cc-ac9c9cdea100 | 2023-01-27 | Warnings, Adverse reactions | 091368 ANDA091368 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62332-169-10 | 62332016910 | 100 BLISTER PACK in 1 CARTON (62332-169-10) / 10 TABLET in 1 BLISTER PACK | 100 blister pack | 2026-09-22 | No | No | Current |
| 62332-169-30 | 62332016930 | 30 TABLET in 1 BOTTLE (62332-169-30) | 30 tablet | 2026-09-22 | No | No | Current |
| 62332-169-31 | 62332016931 | 100 TABLET in 1 BOTTLE (62332-169-31) | 100 tablet | 2026-09-22 | No | No | Current |
| 62332-169-60 | 62332016960 | 60 TABLET in 1 BOTTLE (62332-169-60) | 60 tablet | 2026-09-22 | No | No | Current |
| 62332-169-71 | 62332016971 | 500 TABLET in 1 BOTTLE (62332-169-71) | 500 tablet | 2026-09-22 | No | No | Current |
| 62332-169-91 | 62332016991 | 1000 TABLET in 1 BOTTLE (62332-169-91) | 1000 tablet | 2026-09-22 | No | No | Current |