clonidine hydrochloride

Product NDC
53217-215
11-digit product format
532170215
Labeler code
53217
Product ID
53217-215_542bc4f0-6834-4f25-8886-88d926505a2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078895
Marketing category
ANDA
Marketing start
2009-09-21
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
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-215-15clonidine hydrochloride15 in 1 BOTTLETABLET151
53217-215-30clonidine hydrochloride30 in 1 BOTTLETABLET301
53217-215-60clonidine hydrochloride60 in 1 BOTTLETABLET601
53217-215-90clonidine hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-215-15EA - Each53217-21588a6881c-fa59-48cb-817b-9113a1d380cd12016-12-07
53217-215-30EA - Each53217-215d5f8a468-0f1e-4448-a4ec-ca2a050f170812016-12-07
53217-215-60EA - Each53217-215612c6d42-e907-4c0a-bd15-54c2e5d31fb012016-12-07
53217-215-90EA - Each53217-21544c880c2-54d9-4da9-948d-1e422dd7285312016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-215CLONIDINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20161118_5c7f5edd-10b1-49e8-b6ee-23f412caaa8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSN5c7f5edd-10b1-49e8-b6ee-23f412caaa8f1
884185clonidine hydrochloride 0.2 MG Oral TabletSCD5c7f5edd-10b1-49e8-b6ee-23f412caaa8f1
884185clonidine HCl 200 MCG Oral TabletSY5c7f5edd-10b1-49e8-b6ee-23f412caaa8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-215-155321702151515 in 1 BOTTLEHistorical
53217-215-305321702153030 in 1 BOTTLEHistorical
53217-215-605321702156060 in 1 BOTTLEHistorical
53217-215-905321702159090 in 1 BOTTLEHistorical