Clonidine
- Product NDC
- 39822-2010
- 11-digit product format
- 398222010
- Labeler code
- 39822
- Product ID
- 39822-2010_103027a7-2f0d-8d8c-e063-6294a90aedc7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clonidine
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA203167
- Marketing category
- ANDA
- Marketing start
- 2013-10-29
- Substance
- CLONIDINE HYDROCHLORIDE
- Active strength
- 500 ug/mL
- 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
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 |
|---|---|---|---|---|---|---|
| 39822-2010-1 | Clonidine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 14 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | W76I6XXF06 | CLONIDINE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 5 | |
| CLONIDINE | ACTIVE MOIETY | MN3L5RMN02 | CLONIDINE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CLONIDINE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 39822-2010 | CLONIDINE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] | 14 | Current NDC, Legacy NDC, 1 package rows | 20240202_ada02f1f-ae78-4435-879e-492ae862d504.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 884221 | cloNIDine HCl 1000 MCG in 10 ML Injection | PSN | ada02f1f-ae78-4435-879e-492ae862d504 | 14 |
| 884225 | cloNIDine HCl 5000 MCG in 10 ML Injection | PSN | ada02f1f-ae78-4435-879e-492ae862d504 | 14 |
| 884221 | 10 ML clonidine hydrochloride 0.1 MG/ML Injection | SCD | ada02f1f-ae78-4435-879e-492ae862d504 | 14 |
| 884225 | 10 ML clonidine hydrochloride 0.5 MG/ML Injection | SCD | ada02f1f-ae78-4435-879e-492ae862d504 | 14 |
| 884221 | clonidine HCl 1000 MCG per 10 ML Injection | SY | ada02f1f-ae78-4435-879e-492ae862d504 | 14 |
| 884225 | clonidine HCl 5000 MCG per 10 ML Injection | SY | ada02f1f-ae78-4435-879e-492ae862d504 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 39822-2010-1 | 39822201001 | 10 mL in 1 VIAL, SINGLE-DOSE (39822-2010-1) | 10 ml | 2013-10-29 | 0000-00-00 | No | No | Current |