FDA.reportPublic FDA data

Clonidine

Product NDC
0378-0873
11-digit product format
003780873
Labeler code
0378
Product ID
0378-0873_9979db75-b038-418e-b527-724d23c65932
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076166
Marketing category
ANDA
Marketing start
2013-03-01
Substance
CLONIDINE
Active strength
.3 mg/d
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/d

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
0378-0873-16Clonidine1 in 1 POUCHPATCH112
0378-0873-16Clonidine7 d in 1 PATCHPATCH712
0378-0873-99Clonidine4 in 1 CARTONPATCH412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0873-16EA - Each0378-0873d3980cb5-305f-40b3-83d4-eb7b1c9e5c0e12017-06-15
0378-0873-99EA - Each0378-0873d09f2a7b-8382-4ad7-a835-d6ec5e054a7c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINEACTIVE INGREDIENTMN3L5RMN02CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]8
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]8
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0873CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 3 package rows20230421_7adfc439-e6d0-4593-87dd-0eef36d33c6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998671cloNIDine HCl 0.1 MG/Day Weekly Transdermal SystemPSN7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998675cloNIDine HCl 0.2 MG/Day Weekly Transdermal SystemPSN7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998679cloNIDine HCl 0.3 MG/Day Weekly Transdermal SystemPSN7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998671168 HR clonidine 0.00417 MG/HR Transdermal SystemSCD7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998675168 HR clonidine 0.00833 MG/HR Transdermal SystemSCD7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998679168 HR clonidine 0.0125 MG/HR Transdermal SystemSCD7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998671clonidine HCl 0.1 MG/Day Weekly Transdermal SystemSY7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998675clonidine HCl 0.2 MG/Day Weekly Transdermal SystemSY7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998679clonidine HCl 0.3 MG/Day Weekly Transdermal SystemSY7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998671clonidine hydrochloride 0.1 MG/Day Weekly Transdermal PatchSY7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998675clonidine hydrochloride 0.2 MG/Day Weekly Transdermal PatchSY7adfc439-e6d0-4593-87dd-0eef36d33c6d12
998679clonidine hydrochloride 0.3 MG/Day Weekly Transdermal PatchSY7adfc439-e6d0-4593-87dd-0eef36d33c6d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0873-16003780873161 in 1 POUCHHistorical
0378-0873-99003780873994 POUCH in 1 CARTON (0378-0873-99) / 1 PATCH in 1 POUCH (0378-0873-16) / 7 d in 1 PATCH4 pouch2013-03-010000-00-00NoNoCurrent