FDA.reportPublic FDA data

CLONIDINE HYDROCHLORIDE

Product NDC
53489-217
11-digit product format
534890217
Labeler code
53489
Product ID
53489-217_c0fc5006-ac11-423d-b189-7e95f5fe8d99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mutual Pharmaceutical Company, Inc.
Application
ANDA070923
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
53489-217-012019-11-27C16284748780-19855e2a2-4218-60a7-e053-dbdaa90a05bdCLONIDINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-217-01CLONIDINE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-217CLONIDINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]7Legacy NDC, 1 package rows20140927_a756191e-085a-4a1a-bb88-b7c174cdcefd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSN8c7e0bca-4855-4018-8bf5-3f9ec5b2e64e8
884189clonidine hydrochloride 0.3 MG Oral TabletSCD8c7e0bca-4855-4018-8bf5-3f9ec5b2e64e8
884189clonidine HCl 300 MCG Oral TabletSY8c7e0bca-4855-4018-8bf5-3f9ec5b2e64e8
884173cloNIDine HCl 0.1 MG Oral TabletPSNa756191e-085a-4a1a-bb88-b7c174cdcefd7
884185cloNIDine HCl 0.2 MG Oral TabletPSNa756191e-085a-4a1a-bb88-b7c174cdcefd7
884189cloNIDine HCl 0.3 MG Oral TabletPSNa756191e-085a-4a1a-bb88-b7c174cdcefd7
884173clonidine hydrochloride 0.1 MG Oral TabletSCDa756191e-085a-4a1a-bb88-b7c174cdcefd7
884185clonidine hydrochloride 0.2 MG Oral TabletSCDa756191e-085a-4a1a-bb88-b7c174cdcefd7
884189clonidine hydrochloride 0.3 MG Oral TabletSCDa756191e-085a-4a1a-bb88-b7c174cdcefd7
884173clonidine HCl 100 MCG Oral TabletSYa756191e-085a-4a1a-bb88-b7c174cdcefd7
884185clonidine HCl 200 MCG Oral TabletSYa756191e-085a-4a1a-bb88-b7c174cdcefd7
884189clonidine HCl 300 MCG Oral TabletSYa756191e-085a-4a1a-bb88-b7c174cdcefd7
884173cloNIDine HCl 0.1 MG Oral TabletPSN3b373f21-1fdb-4701-9193-1120337f3f985
884185cloNIDine HCl 0.2 MG Oral TabletPSN3b373f21-1fdb-4701-9193-1120337f3f985
884189cloNIDine HCl 0.3 MG Oral TabletPSN3b373f21-1fdb-4701-9193-1120337f3f985
884173clonidine hydrochloride 0.1 MG Oral TabletSCD3b373f21-1fdb-4701-9193-1120337f3f985
884185clonidine hydrochloride 0.2 MG Oral TabletSCD3b373f21-1fdb-4701-9193-1120337f3f985
884189clonidine hydrochloride 0.3 MG Oral TabletSCD3b373f21-1fdb-4701-9193-1120337f3f985
884173clonidine HCl 100 MCG Oral TabletSY3b373f21-1fdb-4701-9193-1120337f3f985
884185clonidine HCl 200 MCG Oral TabletSY3b373f21-1fdb-4701-9193-1120337f3f985
884189clonidine HCl 300 MCG Oral TabletSY3b373f21-1fdb-4701-9193-1120337f3f985
884173cloNIDine HCl 0.1 MG Oral TabletPSN23f20b4e-e90a-4634-ab69-168151b4e90b2
884185cloNIDine HCl 0.2 MG Oral TabletPSN23f20b4e-e90a-4634-ab69-168151b4e90b2
884189cloNIDine HCl 0.3 MG Oral TabletPSN23f20b4e-e90a-4634-ab69-168151b4e90b2
884173clonidine hydrochloride 0.1 MG Oral TabletSCD23f20b4e-e90a-4634-ab69-168151b4e90b2
884185clonidine hydrochloride 0.2 MG Oral TabletSCD23f20b4e-e90a-4634-ab69-168151b4e90b2
884189clonidine hydrochloride 0.3 MG Oral TabletSCD23f20b4e-e90a-4634-ab69-168151b4e90b2
884173clonidine HCl 100 MCG Oral TabletSY23f20b4e-e90a-4634-ab69-168151b4e90b2
884185clonidine HCl 200 MCG Oral TabletSY23f20b4e-e90a-4634-ab69-168151b4e90b2
884189clonidine HCl 300 MCG Oral TabletSY23f20b4e-e90a-4634-ab69-168151b4e90b2
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
53489-217-0153489021701100 in 1 BOTTLE, PLASTICHistorical