Clonidine hydrochloride
- Product NDC
- 52817-183
- 11-digit product format
- 528170183
- Labeler code
- 52817
- Product ID
- 52817-183_4feb108f-0b2f-75d1-e063-6394a90a6152
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clonidine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TruPharma, LLC
- Application
- ANDA070923
- Marketing category
- ANDA
- Marketing start
- 2026-04-13
- 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
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 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | W76I6XXF06 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52817-183-10 | Clonidine hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52817-183-10 | EA - Each | 52817-183 | 2c2e9a2d-2bac-47bc-8a44-50907a85bae3 | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 884173 | cloNIDine HCl 0.1 MG Oral Tablet | PSN | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 884185 | cloNIDine HCl 0.2 MG Oral Tablet | PSN | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 884189 | cloNIDine HCl 0.3 MG Oral Tablet | PSN | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 2740803 | cloNIDine hydrochloride 0.05 MG Oral Tablet | PSN | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 2740803 | clonidine hydrochloride 0.05 MG Oral Tablet | SCD | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 884173 | clonidine hydrochloride 0.1 MG Oral Tablet | SCD | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 884185 | clonidine hydrochloride 0.2 MG Oral Tablet | SCD | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 884189 | clonidine hydrochloride 0.3 MG Oral Tablet | SCD | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 884173 | clonidine HCl 100 MCG Oral Tablet | SY | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 884185 | clonidine HCl 200 MCG Oral Tablet | SY | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 884189 | clonidine HCl 300 MCG Oral Tablet | SY | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
| 2740803 | clonidine hydrochloride 50 MCG Oral Tablet | SY | c83e4e4f-bd0e-449d-958a-dc0d570a01ba | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52817-183-10 | 52817018310 | 100 TABLET in 1 BOTTLE (52817-183-10) | 100 tablet | 2026-04-13 | No | No | Current |