FDA.reportPublic FDA data

Clonidine

Product NDC
50742-247
11-digit product format
507420247
Labeler code
50742
Product ID
50742-247_4f2ad773-518b-4532-bb69-8ff28c4f24c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA209675
Marketing category
ANDA
Marketing start
2019-03-05
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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui1013930

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
50742-247-05Clonidine500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
50742-247-30Clonidine30 in 1 BOTTLETABLET, EXTENDED RELEASE305
50742-247-60Clonidine60 in 1 BOTTLETABLET, EXTENDED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-247-60EA - Each50742-2472995cb3c-65c5-483a-bee8-194144632b4112019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-247CLONIDINE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 3 package rows20221217_99485427-a120-4fc7-bb61-25857d1900ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN99485427-a120-4fc7-bb61-25857d1900ec5
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD99485427-a120-4fc7-bb61-25857d1900ec5
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY99485427-a120-4fc7-bb61-25857d1900ec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-247-0550742024705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-247-05) 2019-03-050000-00-00NoNoCurrent
50742-247-305074202473030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-247-30) 2019-03-050000-00-00NoNoCurrent
50742-247-605074202476060 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-247-60) 2019-03-050000-00-00NoNoCurrent