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

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE500 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884221, 884225

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-2010-1Clonidine10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]5
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCLONIDINE INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-2010CLONIDINE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]14Current NDC, Legacy NDC, 1 package rows20240202_ada02f1f-ae78-4435-879e-492ae862d504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884221cloNIDine HCl 1000 MCG in 10 ML InjectionPSNada02f1f-ae78-4435-879e-492ae862d50414
884225cloNIDine HCl 5000 MCG in 10 ML InjectionPSNada02f1f-ae78-4435-879e-492ae862d50414
88422110 ML clonidine hydrochloride 0.1 MG/ML InjectionSCDada02f1f-ae78-4435-879e-492ae862d50414
88422510 ML clonidine hydrochloride 0.5 MG/ML InjectionSCDada02f1f-ae78-4435-879e-492ae862d50414
884221clonidine HCl 1000 MCG per 10 ML InjectionSYada02f1f-ae78-4435-879e-492ae862d50414
884225clonidine HCl 5000 MCG per 10 ML InjectionSYada02f1f-ae78-4435-879e-492ae862d50414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-2010-13982220100110 mL in 1 VIAL, SINGLE-DOSE (39822-2010-1) 10 ml2013-10-290000-00-00NoNoCurrent