FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
40042-052
11-digit product format
400420052
Labeler code
40042
Product ID
40042-052_f89df25e-bb64-4351-b3b4-c3eb34843648
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL
Labeler
PharmaForce, Inc.
Application
ANDA091104
Marketing category
ANDA
Marketing start
2009-10-16
Marketing end
0000-00-00
Substance
CLONIDINE HYDROCHLORIDE
Active strength
100 ug/mL
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40042-052-102019-10-21C16284748780-1956f9ecf-cba9-621f-e053-dbdaa90a74adCLONIDINE HYDROCHLORIDE INJECTION Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40042-052-10Clonidine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]2
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40042-052CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [PHARMAFORCE, INC.]2Legacy NDC, 1 package rows20091020_6e562c90-2e37-47ac-9c3f-12460f96dc33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884221cloNIDine HCl 1000 MCG in 10 ML InjectionPSN6e562c90-2e37-47ac-9c3f-12460f96dc332
884225cloNIDine HCl 5000 MCG in 10 ML InjectionPSN6e562c90-2e37-47ac-9c3f-12460f96dc332
88422110 ML clonidine hydrochloride 0.1 MG/ML InjectionSCD6e562c90-2e37-47ac-9c3f-12460f96dc332
88422510 ML clonidine hydrochloride 0.5 MG/ML InjectionSCD6e562c90-2e37-47ac-9c3f-12460f96dc332
884221clonidine HCl 1000 MCG per 10 ML InjectionSY6e562c90-2e37-47ac-9c3f-12460f96dc332
884225clonidine HCl 5000 MCG per 10 ML InjectionSY6e562c90-2e37-47ac-9c3f-12460f96dc332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
40042-052-104004200521010 mL in 1 VIAL10 mlHistorical