FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
66336-786
11-digit product format
663360786
Labeler code
66336
Product ID
66336-786_bdaaa82c-2eae-48cb-832f-4a7f4b2c1fd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA077901
Marketing category
ANDA
Marketing start
2007-03-09
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
66336-786-122019-11-27C16284748780-19855d018-da30-cd31-e053-dbdaa90ab51aCLONIDINE HYDROCHLORIDE TABLETS, USP
66336-786-942019-11-27C16284748780-19855d018-da30-cd31-e053-dbdaa90ab51aCLONIDINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-786-12Clonidine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET122
66336-786-94Clonidine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-786CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 2 package rows20130820_defc0e8b-6ffd-43f9-a88d-5c4afb2b8060.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNdefc0e8b-6ffd-43f9-a88d-5c4afb2b80602
884173clonidine hydrochloride 0.1 MG Oral TabletSCDdefc0e8b-6ffd-43f9-a88d-5c4afb2b80602
884173clonidine HCl 100 MCG Oral TabletSYdefc0e8b-6ffd-43f9-a88d-5c4afb2b80602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-786-126633607861212 in 1 BOTTLE, PLASTICHistorical
66336-786-9466336078694120 in 1 BOTTLE, PLASTICHistorical