FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
68071-3016
11-digit product format
680713016
Labeler code
68071
Product ID
68071-3016_348e120b-bd70-b18a-e063-6394a90ab925
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.2 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.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884185

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
68071-3016-62024-07-17C16284748780-1ba0f9c33-2d5d-a910-e053-dadaa90a0b85Clonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
68071-3016-92024-07-17C16284748780-1ba0f9c33-2d5d-a910-e053-dadaa90a0b85Clonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
68071-3016-62023-01-30C16284748780-1ba0f9c33-2d5d-a910-e053-dadaa90a0b85Clonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
68071-3016-92023-01-30C16284748780-1ba0f9c33-2d5d-a910-e053-dadaa90a0b85Clonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
68071-3016-62021-02-11C16284748780-1ba0f9c33-2d5d-a910-e053-dadaa90a0b85Clonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information
68071-3016-62021-01-29C16284748780-1ba0f9c33-2d5d-a910-e053-dadaa90a0b85Clonidine Hydrochloride Tablets, USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3016-6clonidine hydrochloride60 in 1 BOTTLETABLET605
68071-3016-9clonidine hydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3016CLONIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20250508_746dcdfd-7dfb-4a29-e053-2991aa0a8a4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSN746dcdfd-7dfb-4a29-e053-2991aa0a8a4c5
884185clonidine hydrochloride 0.2 MG Oral TabletSCD746dcdfd-7dfb-4a29-e053-2991aa0a8a4c5
884185clonidine HCl 200 MCG Oral TabletSY746dcdfd-7dfb-4a29-e053-2991aa0a8a4c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3016-66807130160660 TABLET in 1 BOTTLE (68071-3016-6) 60 tablet2018-08-270000-00-00NoNoCurrent
68071-3016-96807130160990 TABLET in 1 BOTTLE (68071-3016-9) 90 tablet2018-08-270000-00-00NoNoCurrent