clonidine hydrochloride

Product NDC
43063-925
11-digit product format
430630925
Labeler code
43063
Product ID
43063-925_52ba35ef-e69a-ca6e-e063-6394a90af9dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078895
Marketing category
ANDA
Marketing start
2009-09-21
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884185

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-925-30clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-925-30EA - Each43063-925715d1c8e-ee52-48b2-b335-b70399a4640312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-925CLONIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 1 package rows20241018_ea1527a5-4939-4ff7-a827-f88a9113a07d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSNea1527a5-4939-4ff7-a827-f88a9113a07d15
884185clonidine hydrochloride 0.2 MG Oral TabletSCDea1527a5-4939-4ff7-a827-f88a9113a07d15
884185clonidine HCl 200 MCG Oral TabletSYea1527a5-4939-4ff7-a827-f88a9113a07d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-925-304306309253030 TABLET in 1 BOTTLE, PLASTIC (43063-925-30) 30 tablet2019-01-070000-00-00NoNoCurrent