FDA.reportPublic FDA data

CLONIDINE HYDROCHLORIDE

Product NDC
61919-266
11-digit product format
619190266
Labeler code
61919
Product ID
61919-266_9c9341dc-c33e-9189-e053-2995a90a4c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA070974
Marketing category
ANDA
Marketing start
2014-01-01
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
2021-12-31
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
61919-266-602023-01-30C16284748780-1f386c64a-3b61-0266-e053-dadaa90a7c1aCLONIDINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-266-30CLONIDINE HYDROCHLORIDE30 in 1 BOTTLETABLET303
61919-266-60CLONIDINE HYDROCHLORIDE60 in 1 BOTTLETABLET603
61919-266-90CLONIDINE HYDROCHLORIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-266-30EA - Each61919-2664f1eb55e-fd95-4679-9e68-1956b75c16f012014-12-01
61919-266-60EA - Each61919-266fb5612ce-dd07-40c4-8ca1-7de2aa29cba512015-02-02
61919-266-90EA - Each61919-26696142d10-545a-46a2-b8ba-ffdffa1d576312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-266CLONIDINE HYDROCHLORIDE TABLET [DIRECT RX]3Legacy NDC, 3 package rows20200121_e6583ff5-0e03-470b-a986-35770aa0e80b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNe6583ff5-0e03-470b-a986-35770aa0e80b3
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe6583ff5-0e03-470b-a986-35770aa0e80b3
884173clonidine HCl 100 MCG Oral TabletSYe6583ff5-0e03-470b-a986-35770aa0e80b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-266-306191902663030 in 1 BOTTLEHistorical
61919-266-606191902666060 BOTTLE in 1 BOTTLE (61919-266-60) > 30 BOTTLE in 1 BOTTLE (61919-266-30) > 90 TABLET in 1 BOTTLE (61919-266-90) 60 bottle2015-01-010000-00-00NoNoCurrent
61919-266-906191902669090 in 1 BOTTLEHistorical