Clonidine

Product NDC
68134-603
11-digit product format
681340603
Labeler code
68134
Product ID
68134-603_0eb6eb87-c779-3b79-e063-6294a90a5944
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PALMETTO PHARMACEUTICALS INC.
Application
NDA022500
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-03-01
Substance
CLONIDINE
Active strength
.17 mg/1
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.17 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMN3L5RMN02
Rxcui885880

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
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
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68134-603-30Clonidine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68134-603-30EA - Each68134-603e7133776-4152-4ed1-83f7-f2cbdf46d95712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68134-603CLONIDINE TABLET, EXTENDED RELEASE [PALMETTO PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 1 package rows20240113_e93324f1-ad83-7bbe-e053-2995a90a8c9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885880cloNIDine 0.17 MG 24HR Extended Release Oral TabletPSNe93324f1-ad83-7bbe-e053-2995a90a8c9e2
88588024 HR clonidine 0.17 MG Extended Release Oral TabletSCDe93324f1-ad83-7bbe-e053-2995a90a8c9e2
885880clonidine 0.17 MG (equivalent to clonidine HCl 0.2 MG) 24 HR Extended Release Oral TabletSYe93324f1-ad83-7bbe-e053-2995a90a8c9e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68134-603-306813406033030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68134-603-30) 2022-03-010000-00-00NoNoCurrent