Clonidine HYDROCHLORIDE

Product NDC
12634-465
11-digit product format
126340465
Labeler code
12634
Product ID
12634-465_91f3b736-ecf5-4517-b8d9-a151308db836
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca, Inc
Application
ANDA070974
Marketing category
ANDA
Marketing start
1996-12-21
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
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-465-01Clonidine HYDROCHLORIDE100 in 1 PACKAGETABLET1001
12634-465-18Clonidine HYDROCHLORIDE180 in 1 BOTTLETABLET1801
12634-465-60Clonidine HYDROCHLORIDE60 in 1 BOTTLETABLET601
12634-465-71Clonidine HYDROCHLORIDE30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXCLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-465CLONIDINE HYDROCHLORIDE TABLET [APOTHECA, INC]1Legacy NDC, 4 package rows20131119_c6c5d645-0003-45d3-80be-1eccae8633ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNc6c5d645-0003-45d3-80be-1eccae8633ad1
884173clonidine hydrochloride 0.1 MG Oral TabletSCDc6c5d645-0003-45d3-80be-1eccae8633ad1
884173clonidine HCl 100 MCG Oral TabletSYc6c5d645-0003-45d3-80be-1eccae8633ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-465-0112634046501100 in 1 PACKAGEHistorical
12634-465-1812634046518180 in 1 BOTTLEHistorical
12634-465-601263404656060 in 1 BOTTLEHistorical
12634-465-711263404657130 in 1 BOTTLEHistorical