CLONIDINE HYDROCHLORIDE

Product NDC
10135-710
11-digit product format
101350710
Labeler code
10135
Product ID
10135-710_ce8104b1-ca95-1808-e053-2995a90a7126
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA202297
Marketing category
ANDA
Marketing start
2020-10-01
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
2022-12-31
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
10135-710-012023-01-30C16284748780-1f386c64a-0d56-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets
10135-710-052023-01-30C16284748780-1f386c64a-0d56-0266-e053-dadaa90a7c1aClonidine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-710-01CLONIDINE HYDROCHLORIDE100 in 1 BOTTLETABLET1003
10135-710-05CLONIDINE HYDROCHLORIDE500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-710-01EA - Each10135-7104f5bec94-acdc-4039-96df-7ce9c31347bb12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-710CLONIDINE HYDROCHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 2 package rows20211018_57ad4805-294a-4b3e-94af-ce3869635d63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN57ad4805-294a-4b3e-94af-ce3869635d633
884185cloNIDine HCl 0.2 MG Oral TabletPSN57ad4805-294a-4b3e-94af-ce3869635d633
884189cloNIDine HCl 0.3 MG Oral TabletPSN57ad4805-294a-4b3e-94af-ce3869635d633
884173clonidine hydrochloride 0.1 MG Oral TabletSCD57ad4805-294a-4b3e-94af-ce3869635d633
884185clonidine hydrochloride 0.2 MG Oral TabletSCD57ad4805-294a-4b3e-94af-ce3869635d633
884189clonidine hydrochloride 0.3 MG Oral TabletSCD57ad4805-294a-4b3e-94af-ce3869635d633
884173clonidine HCl 100 MCG Oral TabletSY57ad4805-294a-4b3e-94af-ce3869635d633
884185clonidine HCl 200 MCG Oral TabletSY57ad4805-294a-4b3e-94af-ce3869635d633
884189clonidine HCl 300 MCG Oral TabletSY57ad4805-294a-4b3e-94af-ce3869635d633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-710-0110135071001100 TABLET in 1 BOTTLE (10135-710-01) 100 tablet2020-10-010000-00-00NoNoCurrent
10135-710-0510135071005500 TABLET in 1 BOTTLE (10135-710-05) 500 tablet2020-10-010000-00-00NoNoCurrent