Clonidine Transdermal System USP, 0.1 mg/day
- Product NDC
- 52817-505
- 11-digit product format
- 528170505
- Labeler code
- 52817
- Product ID
- 52817-505_cb042bcb-7841-43e9-bf1a-0ab908860766
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clonidine transdermal system
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- TruPharma, LLC
- Application
- NDA018891
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2026-03-30
- Substance
- CLONIDINE
- Active strength
- .1 mg/d
- 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 Transdermal System USP, 0.1 mg/day
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLONIDINE | .1 mg/d |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | MN3L5RMN02 |
| Rxcui | 998671, 998675, 998679 |
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 |
|---|---|---|---|---|---|---|
| 52817-505-04 | Clonidine Transdermal System USP, 0.1 mg/day | 4 in 1 CARTON | PATCH | 4 | 1 | |
| 52817-505-04 | Clonidine Transdermal System USP, 0.1 mg/day | 1 in 1 POUCH | PATCH | 1 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998671 | cloNIDine HCl 0.1 MG/Day Weekly Transdermal System | PSN | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998675 | cloNIDine HCl 0.2 MG/Day Weekly Transdermal System | PSN | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998679 | cloNIDine HCl 0.3 MG/Day Weekly Transdermal System | PSN | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998671 | 168 HR clonidine 0.00417 MG/HR Transdermal System | SCD | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998675 | 168 HR clonidine 0.00833 MG/HR Transdermal System | SCD | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998679 | 168 HR clonidine 0.0125 MG/HR Transdermal System | SCD | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998671 | clonidine HCl 0.1 MG/Day Weekly Transdermal System | SY | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998675 | clonidine HCl 0.2 MG/Day Weekly Transdermal System | SY | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998679 | clonidine HCl 0.3 MG/Day Weekly Transdermal System | SY | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998671 | clonidine hydrochloride 0.1 MG/Day Weekly Transdermal Patch | SY | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998675 | clonidine hydrochloride 0.2 MG/Day Weekly Transdermal Patch | SY | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
| 998679 | clonidine hydrochloride 0.3 MG/Day Weekly Transdermal Patch | SY | 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52817-505-04 | 52817050504 | 4 POUCH in 1 CARTON (52817-505-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH | 4 pouch | 2026-03-30 | No | No | Current |