FDA.reportPublic FDA data

Clonidine

Product NDC
75907-023
11-digit product format
759070023
Labeler code
75907
Product ID
75907-023_07b162a5-9473-c1d7-9cba-aef238255dee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONIDINE
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Dr. Reddy's Labratories Inc.
Application
ANDA079090
Marketing category
ANDA
Marketing start
2024-02-10
Substance
CLONIDINE
Active strength
.1 mg/24h
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE.1 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMN3L5RMN02
Rxcui998671, 998675, 998679

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
75907-023-11Clonidine1 in 1 POUCHPATCH, EXTENDED RELEASE11
75907-023-11Clonidine24 h in 1 PATCHPATCH, EXTENDED RELEASE241
75907-023-48Clonidine4 in 1 CARTONPATCH, EXTENDED RELEASE41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-023-11EA - Each75907-0238387daba-5597-46f3-aadf-56bab93990d312025-01-14
75907-023-48EA - Each75907-0236aeb2746-3369-46eb-aef7-b0127a24db9d12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-023CLONIDINE PATCH, EXTENDED RELEASE [DR. REDDY'S LABRATORIES INC.]1Current NDC, 3 package rows20240210_a179570b-eef1-176a-820c-5f603d222a60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998671cloNIDine HCl 0.1 MG/Day Weekly Transdermal SystemPSNa179570b-eef1-176a-820c-5f603d222a601
998675cloNIDine HCl 0.2 MG/Day Weekly Transdermal SystemPSNa179570b-eef1-176a-820c-5f603d222a601
998679cloNIDine HCl 0.3 MG/Day Weekly Transdermal SystemPSNa179570b-eef1-176a-820c-5f603d222a601
998671168 HR clonidine 0.00417 MG/HR Transdermal SystemSCDa179570b-eef1-176a-820c-5f603d222a601
998675168 HR clonidine 0.00833 MG/HR Transdermal SystemSCDa179570b-eef1-176a-820c-5f603d222a601
998679168 HR clonidine 0.0125 MG/HR Transdermal SystemSCDa179570b-eef1-176a-820c-5f603d222a601
998671clonidine HCl 0.1 MG/Day Weekly Transdermal SystemSYa179570b-eef1-176a-820c-5f603d222a601
998675clonidine HCl 0.2 MG/Day Weekly Transdermal SystemSYa179570b-eef1-176a-820c-5f603d222a601
998679clonidine HCl 0.3 MG/Day Weekly Transdermal SystemSYa179570b-eef1-176a-820c-5f603d222a601
998671clonidine hydrochloride 0.1 MG/Day Weekly Transdermal PatchSYa179570b-eef1-176a-820c-5f603d222a601
998675clonidine hydrochloride 0.2 MG/Day Weekly Transdermal PatchSYa179570b-eef1-176a-820c-5f603d222a601
998679clonidine hydrochloride 0.3 MG/Day Weekly Transdermal PatchSYa179570b-eef1-176a-820c-5f603d222a601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-023-11759070023111 in 1 POUCHHistorical
75907-023-48759070023484 POUCH in 1 CARTON (75907-023-48) / 1 PATCH in 1 POUCH (75907-023-11) / 24 h in 1 PATCH4 pouch2024-02-10NoNoHistorical