Clonidine Hydrochloride
- Product NDC
- 43547-435
- 11-digit product format
- 435470435
- Labeler code
- 43547
- Product ID
- 43547-435_7fb6aea0-5714-48f7-9d60-c2e214755977
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clonidine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Solco Healthcare LLC
- Application
- ANDA209757
- Marketing category
- ANDA
- Marketing start
- 2018-02-15
- Substance
- CLONIDINE HYDROCHLORIDE
- Active strength
- .1 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| A209757-001 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209757-001 | AB1 |
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 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209757-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2017-11-20 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209757-001 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209757-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209757-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209757-001 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209757-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209757-001 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209757-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209757-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209757-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209757-001 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209757-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209757-001 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209757-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209757-001 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209757-001 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209757-001 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209757-001 | AB1 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209757-001 | AB1 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A209757-001 | AB1 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209757-001 | AB1 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209757-001 | AB1 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A209757-001 | AB1 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A209757-001 | AB1 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A209757-001 | AB1 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A209757-001 | AB1 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A209757-001 | AB1 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A209757-001 | AB1 | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209757-001 | AB1 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A209757-001 | AB1 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A209757-001 | AB1 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209757-001 | AB1 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209757-001 | AB1 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209757-001 | AB1 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209757-001 | AB1 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A209757-001 | AB1 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A209757-001 | AB1 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209757-001 | AB1 | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A209757-001 | AB1 | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A209757-001 | AB1 | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209757-001 | AB1 | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clonidine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLONIDINE HYDROCHLORIDE | .1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| W76I6XXF06 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1013930 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 03a53175-d301-4001-b28b-78ecd763c4ae | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 45c8ba14-e378-46f0-b21f-1aad8e08c613 | Product name | 1 | 20250221 |
| 6920b0ed-30bc-b127-73e1-0713049bd41e | Product name | 9 | 20190618 |
| 6920b0ed-30bc-b127-73e1-0713049bd41e | Product name | 5 | 20171212 |
| 48f5a4fd-7cdc-dc04-771d-ce7a47326789 | Product name | 2 | 20150123 |
| 624cf764-e200-44b5-83c2-84526255adb5 | Product name | 1 | 20150107 |
| 47972e1b-c905-eeee-5e77-eb4538ad833c | Product name | 1 | 20140508 |
| 7667d8e2-e5be-36e1-4de7-231aa7fdaf5c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-435-06 | Clonidine Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-435-06 | EA - Each | 43547-435 | 4295143b-520c-4a6b-8ad7-9abd39186e5b | 1 | 2018-04-19 |
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 |
|---|---|---|---|---|---|---|
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | 36bd0f0e-5569-466a-ab1b-90eb39efdd68 | 2024-07-16 | Warnings, Adverse reactions | 209757 ANDA209757 |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | 9fb36ee3-3d93-4c2e-b399-691305bac715 | 2024-07-08 | Warnings, Adverse reactions | 209757 ANDA209757 |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Solco Healthcare LLC | 03a53175-d301-4001-b28b-78ecd763c4ae | 2024-05-30 | Warnings, Adverse reactions | 209757 ANDA209757 43547-435 |
| Clonidine Hydrochloride | CLONIDINE HYDROCHLORIDE | Xiamen LP Pharmaceutical Co., Ltd. | 7676af27-4d8f-49c4-a50f-6b0892e73c8f | 2020-10-27 | Warnings, Adverse reactions | 209757 ANDA209757 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1013930 | cloNIDine HCl 0.1 MG 12HR Extended Release Oral Tablet | PSN | 9fb36ee3-3d93-4c2e-b399-691305bac715 | 103 |
| 1013930 | 12 HR clonidine hydrochloride 0.1 MG Extended Release Oral Tablet | SCD | 9fb36ee3-3d93-4c2e-b399-691305bac715 | 103 |
| 1013930 | clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral Tablet | SY | 9fb36ee3-3d93-4c2e-b399-691305bac715 | 103 |
| 1013930 | cloNIDine HCl 0.1 MG 12HR Extended Release Oral Tablet | PSN | 36bd0f0e-5569-466a-ab1b-90eb39efdd68 | 101 |
| 1013930 | 12 HR clonidine hydrochloride 0.1 MG Extended Release Oral Tablet | SCD | 36bd0f0e-5569-466a-ab1b-90eb39efdd68 | 101 |
| 1013930 | clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral Tablet | SY | 36bd0f0e-5569-466a-ab1b-90eb39efdd68 | 101 |
| 1013930 | cloNIDine HCl 0.1 MG 12HR Extended Release Oral Tablet | PSN | 03a53175-d301-4001-b28b-78ecd763c4ae | 7 |
| 1013930 | 12 HR clonidine hydrochloride 0.1 MG Extended Release Oral Tablet | SCD | 03a53175-d301-4001-b28b-78ecd763c4ae | 7 |
| 1013930 | clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral Tablet | SY | 03a53175-d301-4001-b28b-78ecd763c4ae | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43547-435-06 | 43547043506 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-435-06) | 2018-02-15 | 0000-00-00 | No | No | Current |