Clonidine hydrochloride
- Product NDC
- 50090-4360
- 11-digit product format
- 500904360
- Labeler code
- 50090
- Product ID
- 50090-4360_9aeace8f-4d17-4b6c-8fa2-c73560d738c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clonidine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA070925
- Marketing category
- ANDA
- Marketing start
- 2017-06-01
- Marketing end
- 0000-00-00
- Substance
- CLONIDINE HYDROCHLORIDE
- Active strength
- 0 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 product | product | 50090-4360 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 50090-4360 | 50090-4360-0 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 50090-4360 | 50090-4360-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 50090-4360 | 50090-4360-2 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 50090-4360 | 50090-4360-7 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 50090-4360 | 50090-4360-8 | D | Discontinued by firm | 2026-10-05 |
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 | 50090-4360-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4360-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4360-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4360-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4360-7 | 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 | 50090-4360-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4360-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4360-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4360-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4360-7 | 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 | 50090-4360-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-4360-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-4360-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-4360-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-4360-7 | 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 | 50090-4360-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-4360-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-4360-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-4360-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-4360-7 | 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 | 50090-4360-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-4360-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-4360-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-4360-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-4360-7 | 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 | 50090-4360-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-4360-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-4360-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-4360-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-4360-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4360-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4360-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4360-8 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4360-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4360-7 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4360-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4360-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4360-8 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4360-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4360-7 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4360-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4360-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4360-8 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4360-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4360-7 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4360-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4360-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4360-8 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4360-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4360-7 | ad56d346431e… | cc804d4bbf1e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 50090-4360-0 | 2023-02-06 | Clonidine hydrochloride |
| 50090-4360-1 | 2023-02-06 | Clonidine hydrochloride |
| 50090-4360-2 | 2023-02-06 | Clonidine hydrochloride |
| 50090-4360-7 | 2023-02-06 | Clonidine hydrochloride |
| 50090-4360-8 | 2023-02-06 | Clonidine hydrochloride |
| 50090-4360-0 | 2023-01-30 | Clonidine hydrochloride |
| 50090-4360-1 | 2023-01-30 | Clonidine hydrochloride |
| 50090-4360-2 | 2023-01-30 | Clonidine hydrochloride |
| 50090-4360-7 | 2023-01-30 | Clonidine hydrochloride |
| 50090-4360-8 | 2023-01-30 | Clonidine hydrochloride |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4360-0 | EA - Each | 50090-4360 | bb730a1e-ab4c-443f-94e1-4d79e1f6699c | 1 | 2021-04-08 |
| 50090-4360-1 | EA - Each | 50090-4360 | bc980c6d-0e40-4dda-9500-23ac82457421 | 1 | 2022-09-12 |
| 50090-4360-2 | EA - Each | 50090-4360 | 207296e9-33a1-4077-aab8-e494dab10888 | 1 | 2022-09-12 |
| 50090-4360-7 | EA - Each | 50090-4360 | 0290b2ee-cd08-4563-a232-fc8c63f9ee1f | 1 | 2021-08-05 |
| 50090-4360-8 | EA - Each | 50090-4360 | 768d49c2-e19a-4525-a6df-514b0c6ba391 | 1 | 2022-09-12 |
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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4360-0 | 50090436000 | 30 TABLET in 1 BOTTLE (50090-4360-0) | 30 tablet | 2019-06-17 | 0000-00-00 | No | No | Current |
| 50090-4360-1 | 50090436001 | 60 TABLET in 1 BOTTLE (50090-4360-1) | 60 tablet | 2019-06-17 | 0000-00-00 | No | No | Current |
| 50090-4360-2 | 50090436002 | 100 TABLET in 1 BOTTLE (50090-4360-2) | 100 tablet | 2019-06-17 | 0000-00-00 | No | No | Current |
| 50090-4360-7 | 50090436007 | 90 TABLET in 1 BOTTLE (50090-4360-7) | 90 tablet | 2019-06-17 | 0000-00-00 | No | No | Current |
| 50090-4360-8 | 50090436008 | 180 TABLET in 1 BOTTLE (50090-4360-8) | 180 tablet | 2019-06-17 | 0000-00-00 | No | No | Current |