CLONIDINE HYDROCHLORIDE
- Product NDC
- 63629-2753
- Requested package NDC
- 63629-2753-4
- 11-digit product format
- 636292753
- Labeler code
- 63629
- Product ID
- 63629-2753_1e17b4e7-c094-456c-aa6d-487945084931
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clonidine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA070924
- Marketing category
- ANDA
- Marketing start
- 1987-09-04
- 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
- 2021-12-31
- 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 | 63629-2753 | 63629-2753-4 | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
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 |
|---|---|---|
| 63629-2753-1 | 2020-10-16 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-2 | 2020-10-16 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-3 | 2020-10-16 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-4 | 2020-10-16 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-5 | 2020-10-16 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-6 | 2020-10-16 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-7 | 2020-10-16 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-8 | 2020-10-16 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-1 | 2020-01-31 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-2 | 2020-01-31 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-3 | 2020-01-31 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-4 | 2020-01-31 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-5 | 2020-01-31 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-6 | 2020-01-31 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-7 | 2020-01-31 | CLONIDINE HYDROCHLORIDE TABLETS USP |
| 63629-2753-8 | 2020-01-31 | CLONIDINE HYDROCHLORIDE TABLETS USP |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2753-1 | EA - Each | 63629-2753 | 2db9e361-5710-4e8d-b7e5-f73a8640fcbc | 1 | 2012-07-24 |
| 63629-2753-2 | EA - Each | 63629-2753 | 3d5f099a-aa3d-4a7c-a7ab-39b944d1d39d | 1 | 2012-07-24 |
| 63629-2753-3 | EA - Each | 63629-2753 | 591162d6-a1d8-4f4e-8085-72d0c4122ed5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | W76I6XXF06 | CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1002 | |
| CLONIDINE | ACTIVE MOIETY | MN3L5RMN02 | CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1002 |
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 | a32f4b18-1090-4d79-a56b-39c0cf366bbc | 2026-02-05 | Warnings, Adverse reactions | 070924 ANDA070924 |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Northwind Health Company, LLC | df77e732-9765-ee5c-e053-2a95a90abc92 | 2026-01-01 | Warnings, Adverse reactions | 070924 ANDA070924 |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Proficient Rx LP | 8427eee0-955d-4718-b259-73dab56d36d2 | 2023-08-01 | Warnings, Adverse reactions | 070924 ANDA070924 |
| Clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Asclemed USA, Inc. | e8c7aa08-1450-de68-e053-2995a90ad0b6 | 2022-09-16 | Warnings, Adverse reactions | 070924 ANDA070924 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-2753-4 | 63629275304 | 90 TABLET in 1 BOTTLE (63629-2753-4) | 90 tablet | 2006-04-07 | 0000-00-00 | No | No | Current |