Clonidine
- Product NDC
- 0378-0871
- 11-digit product format
- 003780871
- Labeler code
- 0378
- Product ID
- 0378-0871_9979db75-b038-418e-b527-724d23c65932
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clonidine
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076166
- Marketing category
- ANDA
- Marketing start
- 2013-02-25
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clonidine
- Listing expiration
- 2026-12-31
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 |
|---|---|---|---|---|---|---|
| 0378-0871-16 | Clonidine | 1 in 1 POUCH | PATCH | 1 | 12 | |
| 0378-0871-16 | Clonidine | 7 d in 1 PATCH | PATCH | 7 | 12 | |
| 0378-0871-99 | Clonidine | 4 in 1 CARTON | PATCH | 4 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-0871-16 | EA - Each | 0378-0871 | 3594e011-4c72-46fe-bcdd-c2dc43b93c73 | 1 | 2015-05-05 |
| 0378-0871-99 | EA - Each | 0378-0871 | 18d8d8eb-83ea-4456-9573-c8d0b596818f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CLONIDINE | ACTIVE INGREDIENT | MN3L5RMN02 | CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.] | 8 | |
| CLONIDINE | ACTIVE MOIETY | MN3L5RMN02 | CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.] | 8 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.] | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998671 | cloNIDine HCl 0.1 MG/Day Weekly Transdermal System | PSN | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998675 | cloNIDine HCl 0.2 MG/Day Weekly Transdermal System | PSN | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998679 | cloNIDine HCl 0.3 MG/Day Weekly Transdermal System | PSN | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998671 | 168 HR clonidine 0.00417 MG/HR Transdermal System | SCD | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998675 | 168 HR clonidine 0.00833 MG/HR Transdermal System | SCD | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998679 | 168 HR clonidine 0.0125 MG/HR Transdermal System | SCD | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998671 | clonidine HCl 0.1 MG/Day Weekly Transdermal System | SY | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998675 | clonidine HCl 0.2 MG/Day Weekly Transdermal System | SY | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998679 | clonidine HCl 0.3 MG/Day Weekly Transdermal System | SY | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998671 | clonidine hydrochloride 0.1 MG/Day Weekly Transdermal Patch | SY | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998675 | clonidine hydrochloride 0.2 MG/Day Weekly Transdermal Patch | SY | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
| 998679 | clonidine hydrochloride 0.3 MG/Day Weekly Transdermal Patch | SY | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-0871-16 | 00378087116 | 1 in 1 POUCH | Historical | |||||
| 0378-0871-99 | 00378087199 | 4 POUCH in 1 CARTON (0378-0871-99) / 1 PATCH in 1 POUCH (0378-0871-16) / 7 d in 1 PATCH | 4 pouch | 2013-02-25 | 0000-00-00 | No | No | Current |