FDA.reportPublic FDA data

CLONIDINE HYDROCHLORIDE

Product NDC
21695-371
11-digit product format
216950371
Labeler code
21695
Product ID
21695-371_c1143cd8-4325-4dcf-a12f-8badfdba682f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA070925
Marketing category
ANDA
Marketing start
1987-09-04
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
E
Listing certified through
2017-12-31
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
21695-371-002019-09-24C16284748780-1934fe258-474f-48b1-e053-8cdaa90a720aCLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg
21695-371-152019-09-24C16284748780-1934fe258-474f-48b1-e053-8cdaa90a720aCLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg
21695-371-302019-09-24C16284748780-1934fe258-474f-48b1-e053-8cdaa90a720aCLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg
21695-371-602019-09-24C16284748780-1934fe258-474f-48b1-e053-8cdaa90a720aCLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg
21695-371-902019-09-24C16284748780-1934fe258-474f-48b1-e053-8cdaa90a720aCLONIDINE HYDROCHLORIDE USP Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-371-00CLONIDINE HYDROCHLORIDE100 in 1 BOTTLETABLET1001
21695-371-15CLONIDINE HYDROCHLORIDE15 in 1 BOTTLETABLET151
21695-371-30CLONIDINE HYDROCHLORIDE30 in 1 BOTTLETABLET301
21695-371-60CLONIDINE HYDROCHLORIDE60 in 1 BOTTLETABLET601
21695-371-90CLONIDINE HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-371CLONIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 5 package rows20110726_c1143cd8-4325-4dcf-a12f-8badfdba682f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNc1143cd8-4325-4dcf-a12f-8badfdba682f1
884185cloNIDine HCl 0.2 MG Oral TabletPSNc1143cd8-4325-4dcf-a12f-8badfdba682f1
884189cloNIDine HCl 0.3 MG Oral TabletPSNc1143cd8-4325-4dcf-a12f-8badfdba682f1
884173clonidine hydrochloride 0.1 MG Oral TabletSCDc1143cd8-4325-4dcf-a12f-8badfdba682f1
884185clonidine hydrochloride 0.2 MG Oral TabletSCDc1143cd8-4325-4dcf-a12f-8badfdba682f1
884189clonidine hydrochloride 0.3 MG Oral TabletSCDc1143cd8-4325-4dcf-a12f-8badfdba682f1
884173clonidine HCl 100 MCG Oral TabletSYc1143cd8-4325-4dcf-a12f-8badfdba682f1
884185clonidine HCl 200 MCG Oral TabletSYc1143cd8-4325-4dcf-a12f-8badfdba682f1
884189clonidine HCl 300 MCG Oral TabletSYc1143cd8-4325-4dcf-a12f-8badfdba682f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-371-0021695037100100 in 1 BOTTLEHistorical
21695-371-152169503711515 in 1 BOTTLEHistorical
21695-371-302169503713030 in 1 BOTTLEHistorical
21695-371-602169503716060 in 1 BOTTLEHistorical
21695-371-902169503719090 in 1 BOTTLEHistorical