FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
68071-2631
11-digit product format
680712631
Labeler code
68071
Product ID
68071-2631_d6f7e170-858d-9134-e053-2a95a90aac6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202297
Marketing category
ANDA
Marketing start
2020-07-01
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
2023-12-31
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
68071-2631-22025-01-30C16284748780-12cef2736-ac77-d83d-e063-dadaa90ab31fClonidine Hydrochloride Tablets
68071-2631-32025-01-30C16284748780-12cef2736-ac77-d83d-e063-dadaa90ab31fClonidine Hydrochloride Tablets
68071-2631-52025-01-30C16284748780-12cef2736-ac77-d83d-e063-dadaa90ab31fClonidine Hydrochloride Tablets
68071-2631-62025-01-30C16284748780-12cef2736-ac77-d83d-e063-dadaa90ab31fClonidine Hydrochloride Tablets
68071-2631-92025-01-30C16284748780-12cef2736-ac77-d83d-e063-dadaa90ab31fClonidine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2631-2Clonidine Hydrochloride120 in 1 BOTTLETABLET1201
68071-2631-3Clonidine Hydrochloride30 in 1 BOTTLETABLET301
68071-2631-5Clonidine Hydrochloride15 in 1 BOTTLETABLET151
68071-2631-6Clonidine Hydrochloride60 in 1 BOTTLETABLET601
68071-2631-9Clonidine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2631CLONIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 5 package rows20220202_d6f7ebb0-e05e-d382-e053-2a95a90a39f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNd6f7ebb0-e05e-d382-e053-2a95a90a39f21
884173clonidine hydrochloride 0.1 MG Oral TabletSCDd6f7ebb0-e05e-d382-e053-2a95a90a39f21
884173clonidine HCl 100 MCG Oral TabletSYd6f7ebb0-e05e-d382-e053-2a95a90a39f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2631-268071263102120 TABLET in 1 BOTTLE (68071-2631-2) 120 tablet2022-02-010000-00-00NoNoCurrent
68071-2631-36807126310330 TABLET in 1 BOTTLE (68071-2631-3) 30 tablet2022-02-010000-00-00NoNoCurrent
68071-2631-56807126310515 TABLET in 1 BOTTLE (68071-2631-5) 15 tablet2022-02-010000-00-00NoNoCurrent
68071-2631-66807126310660 TABLET in 1 BOTTLE (68071-2631-6) 60 tablet2022-02-010000-00-00NoNoCurrent
68071-2631-96807126310990 TABLET in 1 BOTTLE (68071-2631-9) 90 tablet2022-02-010000-00-00NoNoCurrent