FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
10544-196
11-digit product format
105440196
Labeler code
10544
Product ID
10544-196_104fea5c-cb2d-16c3-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077901
Marketing category
ANDA
Marketing start
2013-11-15
Marketing end
0000-00-00
Substance
CLONIDINE HYDROCHLORIDE
Active strength
0 mg/1
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
10544-196-902020-01-31C16284748780-19d75b9d0-0268-f424-e053-dadaa90a57ceCLONIDINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-196-90Clonidine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-196CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150302_104a3cba-6ed9-48b3-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN104a3cba-6ed9-48b3-e054-00144ff8d46c2
884185cloNIDine HCl 0.2 MG Oral TabletPSN104a3cba-6ed9-48b3-e054-00144ff8d46c2
884173clonidine hydrochloride 0.1 MG Oral TabletSCD104a3cba-6ed9-48b3-e054-00144ff8d46c2
884185clonidine hydrochloride 0.2 MG Oral TabletSCD104a3cba-6ed9-48b3-e054-00144ff8d46c2
884173clonidine HCl 100 MCG Oral TabletSY104a3cba-6ed9-48b3-e054-00144ff8d46c2
884185clonidine HCl 200 MCG Oral TabletSY104a3cba-6ed9-48b3-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-196-901054401969090 in 1 BOTTLE, PLASTICHistorical