FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
66267-061
11-digit product format
662670061
Labeler code
66267
Product ID
66267-061_1f98d40a-8eba-1de2-e063-6394a90aa38b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078895
Marketing category
ANDA
Marketing start
2009-09-21
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173

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
66267-061-302024-08-13C16284748780-1f386c649-fdc4-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets USP
66267-061-602024-08-13C16284748780-1f386c649-fdc4-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets USP
66267-061-902024-08-13C16284748780-1f386c649-fdc4-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets USP
66267-061-302023-01-30C16284748780-1f386c649-fdc4-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets USP
66267-061-602023-01-30C16284748780-1f386c649-fdc4-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets USP
66267-061-902023-01-30C16284748780-1f386c649-fdc4-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-061-30clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET305
66267-061-60clonidine hydrochloride60 in 1 BOTTLE, PLASTICTABLET605
66267-061-90clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-061-30EA - Each66267-061a5f0eca3-d29d-49e6-8ad3-89822c7b62e712016-10-06
66267-061-60EA - Each66267-0618159bc55-e1fa-486b-bc69-2e6a6435d00412016-10-06
66267-061-90EA - Each66267-06185aff42b-5420-471c-93f9-4473c98868a312016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-061CLONIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240815_3d966e77-9331-4051-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN3d966e77-9331-4051-e054-00144ff8d46c5
884173clonidine hydrochloride 0.1 MG Oral TabletSCD3d966e77-9331-4051-e054-00144ff8d46c5
884173clonidine HCl 100 MCG Oral TabletSY3d966e77-9331-4051-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-061-306626700613030 TABLET in 1 BOTTLE, PLASTIC (66267-061-30) 30 tablet2016-09-280000-00-00NoNoCurrent
66267-061-606626700616060 TABLET in 1 BOTTLE, PLASTIC (66267-061-60) 60 tablet2016-09-280000-00-00NoNoCurrent
66267-061-906626700619090 TABLET in 1 BOTTLE, PLASTIC (66267-061-90) 90 tablet2016-09-280000-00-00NoNoCurrent