Clonidine hydrochloride
- Product NDC
- 71335-0922
- 11-digit product format
- 713350922
- Labeler code
- 71335
- Product ID
- 71335-0922_1a487aeb-d565-4e30-b410-1c007e262560
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clonidine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA070925
- Marketing category
- ANDA
- Marketing start
- 2017-06-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0922-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0922-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0922-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0922-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0922-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0922-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0922-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0922-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0922-0 | cdf11ea48f46… | ba0047e9e063… |
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 | .1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| W76I6XXF06 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 884173 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cee049ea-a476-433c-971f-2466a6a3263b | 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 |
|---|---|---|---|---|---|---|
| 71335-0922-0 | Clonidine hydrochloride | 24 in 1 BOTTLE | TABLET | 24 | 5 | |
| 71335-0922-1 | Clonidine hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 71335-0922-2 | Clonidine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 71335-0922-3 | Clonidine hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 5 | |
| 71335-0922-4 | Clonidine hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 71335-0922-5 | Clonidine hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | 5 | |
| 71335-0922-6 | Clonidine hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 5 | |
| 71335-0922-7 | Clonidine hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 5 | |
| 71335-0922-8 | Clonidine hydrochloride | 45 in 1 BOTTLE | TABLET | 45 | 5 | |
| 71335-0922-9 | Clonidine hydrochloride | 14 in 1 BOTTLE | TABLET | 14 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-0922 | CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 10 package rows | 20220202_cee049ea-a476-433c-971f-2466a6a3263b.zip |
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 | cee049ea-a476-433c-971f-2466a6a3263b | 2026-06-24 | Warnings, Adverse reactions | 070925 ANDA070925 71335-0922 |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 50c8a725-a449-256b-e063-6294a90a3e44 | 2026-05-01 | Warnings, Adverse reactions | 070925 ANDA070925 |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7484e8fa-13a7-70e9-e053-2a91aa0a24b7 | 2026-03-02 | Warnings, Adverse reactions | 070925 ANDA070925 |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Northwind Health Company, LLC | df603f27-d341-3957-e053-2995a90a825f | 2026-01-01 | Warnings, Adverse reactions | 070925 ANDA070925 |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | Proficient Rx LP | d072d601-b3d2-46e0-af1f-98adc9572f4a | 2025-10-01 | Warnings, Adverse reactions | 070925 ANDA070925 |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Asclemed USA, Inc. | e8c7aa08-1450-de68-e053-2995a90ad0b6 | 2022-09-16 | Warnings, Adverse reactions | 070925 ANDA070925 |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Proficient Rx LP | 33c68d5e-6a68-40fd-a326-bf36a7e01d5b | 2022-09-01 | Warnings, Adverse reactions | 070925 ANDA070925 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 884173 | cloNIDine HCl 0.1 MG Oral Tablet | PSN | cee049ea-a476-433c-971f-2466a6a3263b | 5 |
| 884173 | clonidine hydrochloride 0.1 MG Oral Tablet | SCD | cee049ea-a476-433c-971f-2466a6a3263b | 5 |
| 884173 | clonidine HCl 100 MCG Oral Tablet | SY | cee049ea-a476-433c-971f-2466a6a3263b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0922-0 | 71335092200 | 24 TABLET in 1 BOTTLE (71335-0922-0) | 24 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-0922-1 | 71335092201 | 100 TABLET in 1 BOTTLE (71335-0922-1) | 100 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-0922-2 | 71335092202 | 30 TABLET in 1 BOTTLE (71335-0922-2) | 30 tablet | 2018-08-28 | 0000-00-00 | No | No | Current |
| 71335-0922-3 | 71335092203 | 20 TABLET in 1 BOTTLE (71335-0922-3) | 20 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-0922-4 | 71335092204 | 60 TABLET in 1 BOTTLE (71335-0922-4) | 60 tablet | 2020-03-31 | 0000-00-00 | No | No | Current |
| 71335-0922-5 | 71335092205 | 120 TABLET in 1 BOTTLE (71335-0922-5) | 120 tablet | 2020-03-03 | 0000-00-00 | No | No | Current |
| 71335-0922-6 | 71335092206 | 90 TABLET in 1 BOTTLE (71335-0922-6) | 90 tablet | 2018-08-03 | 0000-00-00 | No | No | Current |
| 71335-0922-7 | 71335092207 | 10 TABLET in 1 BOTTLE (71335-0922-7) | 10 tablet | 2018-09-25 | 0000-00-00 | No | No | Current |
| 71335-0922-8 | 71335092208 | 45 TABLET in 1 BOTTLE (71335-0922-8) | 45 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-0922-9 | 71335092209 | 14 TABLET in 1 BOTTLE (71335-0922-9) | 14 tablet | 2020-01-16 | 0000-00-00 | No | No | Current |