FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
27241-108
11-digit product format
272410108
Labeler code
27241
Product ID
27241-108_ab37a98e-cfb2-4aca-92da-68dedfb13657
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA209686
Marketing category
ANDA
Marketing start
2017-11-21
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
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
27241-108-06Clonidine hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-108-06EA - Each27241-108c7e18cd7-d888-4149-8f34-f8a3b1dbc75c12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-108CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.]8Current NDC, Legacy NDC, 1 package rows20230629_df80255e-f942-4d9f-8edd-cc95795772cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSNdf80255e-f942-4d9f-8edd-cc95795772cb9
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCDdf80255e-f942-4d9f-8edd-cc95795772cb9
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSYdf80255e-f942-4d9f-8edd-cc95795772cb9
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN95b390cc-0578-4cb0-9c08-4853388b2ec94
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD95b390cc-0578-4cb0-9c08-4853388b2ec94
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY95b390cc-0578-4cb0-9c08-4853388b2ec94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-108-062724101080660 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-108-06) 2017-11-210000-00-00NoNoCurrent