FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
43547-435
11-digit product format
435470435
Labeler code
43547
Product ID
43547-435_7fb6aea0-5714-48f7-9d60-c2e214755977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA209757
Marketing category
ANDA
Marketing start
2018-02-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-435-062020-03-04C16284748780-19d75b9d0-69ca-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. CLONIDINE HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1974
43547-435-062020-01-31C16284748780-19d75b9d0-69ca-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. CLONIDINE HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-435-06Clonidine Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-435-06EA - Each43547-4354295143b-520c-4a6b-8ad7-9abd39186e5b12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-435CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE LLC]7Current NDC, Legacy NDC, 1 package rows20240606_03a53175-d301-4001-b28b-78ecd763c4ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN9fb36ee3-3d93-4c2e-b399-691305bac715103
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD9fb36ee3-3d93-4c2e-b399-691305bac715103
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY9fb36ee3-3d93-4c2e-b399-691305bac715103
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN36bd0f0e-5569-466a-ab1b-90eb39efdd68101
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD36bd0f0e-5569-466a-ab1b-90eb39efdd68101
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY36bd0f0e-5569-466a-ab1b-90eb39efdd68101
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN03a53175-d301-4001-b28b-78ecd763c4ae7
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD03a53175-d301-4001-b28b-78ecd763c4ae7
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY03a53175-d301-4001-b28b-78ecd763c4ae7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-435-064354704350660 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-435-06) 2018-02-150000-00-00NoNoCurrent