Clonidine

Product NDC
52817-375
11-digit product format
528170375
Labeler code
52817
Product ID
52817-375_0eb6d1fe-949a-312a-e063-6294a90ae10c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TruPharma, LLC
Application
NDA022500
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-01-11
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
52817-375-30Clonidine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-375-30EA - Each52817-37534f5d8cc-3974-41c5-b150-6cd474736f7412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-375CLONIDINE TABLET, EXTENDED RELEASE [TRUPHARMA, LLC]1Current NDC, 1 package rows20240113_2311836b-de63-4e8c-a021-600c40110024.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885880cloNIDine 0.17 MG 24HR Extended Release Oral TabletPSN2311836b-de63-4e8c-a021-600c401100241
88588024 HR clonidine 0.17 MG Extended Release Oral TabletSCD2311836b-de63-4e8c-a021-600c401100241
885880clonidine 0.17 MG (equivalent to clonidine HCl 0.2 MG) 24 HR Extended Release Oral TabletSY2311836b-de63-4e8c-a021-600c401100241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
52817-375-305281703753030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52817-375-30) 2024-01-11NoNoHistorical