FDA.reportPublic FDA data

Clonidine

Product NDC
51862-455
11-digit product format
518620455
Labeler code
51862
Product ID
51862-455_3dfdaa58-ccab-5f9a-e063-6394a90a3cbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONIDINE
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Mayne Pharma Inc.
Application
ANDA079090
Marketing category
ANDA
Marketing start
2016-08-03
Substance
CLONIDINE
Active strength
.3 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.3 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
51862-455-01Clonidine1 in 1 POUCHPATCH, EXTENDED RELEASE111
51862-455-01Clonidine24 h in 1 PATCHPATCH, EXTENDED RELEASE2411
51862-455-04Clonidine4 in 1 CARTONPATCH, EXTENDED RELEASE411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-455-01EA - Each51862-455b71b672f-a3ba-4579-a27d-755ddaa0bc2b12017-03-06
51862-455-04EA - Each51862-4557866d3bf-e349-42c0-a2b0-2ee9d25b714a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-455CLONIDINE PATCH, EXTENDED RELEASE [MAYNE PHARMA INC.]9Current NDC, Legacy NDC, 3 package rows20250516_c41eb913-5e47-46c4-9d96-9a67f8380919.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998671cloNIDine HCl 0.1 MG/Day Weekly Transdermal SystemPSNc41eb913-5e47-46c4-9d96-9a67f838091911
998675cloNIDine HCl 0.2 MG/Day Weekly Transdermal SystemPSNc41eb913-5e47-46c4-9d96-9a67f838091911
998679cloNIDine HCl 0.3 MG/Day Weekly Transdermal SystemPSNc41eb913-5e47-46c4-9d96-9a67f838091911
998671168 HR clonidine 0.00417 MG/HR Transdermal SystemSCDc41eb913-5e47-46c4-9d96-9a67f838091911
998675168 HR clonidine 0.00833 MG/HR Transdermal SystemSCDc41eb913-5e47-46c4-9d96-9a67f838091911
998679168 HR clonidine 0.0125 MG/HR Transdermal SystemSCDc41eb913-5e47-46c4-9d96-9a67f838091911
998671clonidine HCl 0.1 MG/Day Weekly Transdermal SystemSYc41eb913-5e47-46c4-9d96-9a67f838091911
998675clonidine HCl 0.2 MG/Day Weekly Transdermal SystemSYc41eb913-5e47-46c4-9d96-9a67f838091911
998679clonidine HCl 0.3 MG/Day Weekly Transdermal SystemSYc41eb913-5e47-46c4-9d96-9a67f838091911
998671clonidine hydrochloride 0.1 MG/Day Weekly Transdermal PatchSYc41eb913-5e47-46c4-9d96-9a67f838091911
998675clonidine hydrochloride 0.2 MG/Day Weekly Transdermal PatchSYc41eb913-5e47-46c4-9d96-9a67f838091911
998679clonidine hydrochloride 0.3 MG/Day Weekly Transdermal PatchSYc41eb913-5e47-46c4-9d96-9a67f838091911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-455-01518620455011 in 1 POUCHHistorical
51862-455-04518620455044 POUCH in 1 CARTON (51862-455-04) > 1 PATCH in 1 POUCH (51862-455-01) > 24 h in 1 PATCH4 pouch2016-08-030000-00-00NoNoCurrent