FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
58657-648
11-digit product format
586570648
Labeler code
58657
Product ID
58657-648_2ea9750b-e90d-cc5b-e063-6394a90a7e78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA202297
Marketing category
ANDA
Marketing start
2020-07-01
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.2 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.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173, 884185, 884189

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
58657-648-01Clonidine Hydrochloride100 in 1 BOTTLETABLET1007
58657-648-10Clonidine Hydrochloride1000 in 1 BOTTLETABLET10007
58657-648-50Clonidine Hydrochloride500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-648-01EA - Each58657-648a13b5a9e-c63b-4ad5-8042-80394122611612020-09-14
58657-648-10EA - Each58657-6480623b271-6fb4-442d-bf75-a24d0967622912022-05-04
58657-648-50EA - Each58657-6481eeb28bc-21d5-4433-a562-0b5a6e8726d912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-648CLONIDINE HYDROCHLORIDE TABLET [METHOD PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 3 package rows20250223_dffb5fdd-06c0-4275-9f89-9e12b3adf8a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSN74b40ae9-a9d7-443e-8d7a-80362ec5be6d107
884185clonidine hydrochloride 0.2 MG Oral TabletSCD74b40ae9-a9d7-443e-8d7a-80362ec5be6d107
884185clonidine HCl 200 MCG Oral TabletSY74b40ae9-a9d7-443e-8d7a-80362ec5be6d107
884185cloNIDine HCl 0.2 MG Oral TabletPSN6c95c495-f630-45c1-92c3-8c0fdb22013c106
884185clonidine hydrochloride 0.2 MG Oral TabletSCD6c95c495-f630-45c1-92c3-8c0fdb22013c106
884185clonidine HCl 200 MCG Oral TabletSY6c95c495-f630-45c1-92c3-8c0fdb22013c106
884185cloNIDine HCl 0.2 MG Oral TabletPSN122f6904-bb63-42c5-b000-f4f5c75586cc104
884185clonidine hydrochloride 0.2 MG Oral TabletSCD122f6904-bb63-42c5-b000-f4f5c75586cc104
884185clonidine HCl 200 MCG Oral TabletSY122f6904-bb63-42c5-b000-f4f5c75586cc104
884185cloNIDine HCl 0.2 MG Oral TabletPSNd3b099db-698e-4ea8-a6df-42dc79234597103
884185clonidine hydrochloride 0.2 MG Oral TabletSCDd3b099db-698e-4ea8-a6df-42dc79234597103
884185clonidine HCl 200 MCG Oral TabletSYd3b099db-698e-4ea8-a6df-42dc79234597103
884173cloNIDine HCl 0.1 MG Oral TabletPSNdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884185cloNIDine HCl 0.2 MG Oral TabletPSNe413efdf-980b-4b33-80f1-5be899a10f017
884185cloNIDine HCl 0.2 MG Oral TabletPSNdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884189cloNIDine HCl 0.3 MG Oral TabletPSNdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884173clonidine hydrochloride 0.1 MG Oral TabletSCDdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884185clonidine hydrochloride 0.2 MG Oral TabletSCDe413efdf-980b-4b33-80f1-5be899a10f017
884185clonidine hydrochloride 0.2 MG Oral TabletSCDdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884189clonidine hydrochloride 0.3 MG Oral TabletSCDdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884173clonidine HCl 100 MCG Oral TabletSYdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884185clonidine HCl 200 MCG Oral TabletSYe413efdf-980b-4b33-80f1-5be899a10f017
884185clonidine HCl 200 MCG Oral TabletSYdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884189clonidine HCl 300 MCG Oral TabletSYdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884185cloNIDine HCl 0.2 MG Oral TabletPSN325f382b-6c04-2608-e063-6394a90a38721
884185cloNIDine HCl 0.2 MG Oral TabletPSN5bc6188d-5b51-4dee-a12d-f2d5e42eb88d1
884185clonidine hydrochloride 0.2 MG Oral TabletSCD325f382b-6c04-2608-e063-6394a90a38721
884185clonidine hydrochloride 0.2 MG Oral TabletSCD5bc6188d-5b51-4dee-a12d-f2d5e42eb88d1
884185clonidine HCl 200 MCG Oral TabletSY325f382b-6c04-2608-e063-6394a90a38721
884185clonidine HCl 200 MCG Oral TabletSY5bc6188d-5b51-4dee-a12d-f2d5e42eb88d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-648-0158657064801100 TABLET in 1 BOTTLE (58657-648-01) 100 tablet2020-07-010000-00-00NoNoCurrent
58657-648-10586570648101000 TABLET in 1 BOTTLE (58657-648-10) 1000 tablet2020-07-010000-00-00NoNoCurrent
58657-648-5058657064850500 TABLET in 1 BOTTLE (58657-648-50) 500 tablet2020-07-010000-00-00NoNoCurrent