FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
72789-091
11-digit product format
727890091
Labeler code
72789
Product ID
72789-091_2d66f165-568d-39b5-e063-6394a90a3f66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173

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
72789-091-08clonidine hydrochloride8 in 1 BOTTLE, PLASTICTABLET814
72789-091-15clonidine hydrochloride15 in 1 BOTTLE, PLASTICTABLET1514
72789-091-30clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET3014
72789-091-60clonidine hydrochloride60 in 1 BOTTLE, PLASTICTABLET6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-091-08EA - Each72789-0917aa2ae75-8ae2-432b-bcc6-db92a3e563d812020-09-14
72789-091-15EA - Each72789-091dc04e569-a79f-47bb-9fab-f640f960d7af12021-07-15
72789-091-30EA - Each72789-0915af29320-46ce-4e76-9a7d-0c61eef217db12020-08-06
72789-091-60EA - Each72789-0914b471597-f8c9-4413-a9fd-62add5da474c12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-091CLONIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 4 package rows20250207_5366a055-47fd-41eb-81d8-ffb3be1dc38c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN5366a055-47fd-41eb-81d8-ffb3be1dc38c14
884173clonidine hydrochloride 0.1 MG Oral TabletSCD5366a055-47fd-41eb-81d8-ffb3be1dc38c14
884173clonidine HCl 100 MCG Oral TabletSY5366a055-47fd-41eb-81d8-ffb3be1dc38c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-091-08727890091088 TABLET in 1 BOTTLE, PLASTIC (72789-091-08) 8 tablet2020-08-040000-00-00NoNoCurrent
72789-091-157278900911515 TABLET in 1 BOTTLE, PLASTIC (72789-091-15) 15 tablet2021-05-260000-00-00NoNoCurrent
72789-091-307278900913030 TABLET in 1 BOTTLE, PLASTIC (72789-091-30) 30 tablet2020-06-220000-00-00NoNoCurrent
72789-091-607278900916060 TABLET in 1 BOTTLE, PLASTIC (72789-091-60) 60 tablet2020-07-090000-00-00NoNoCurrent