FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
58657-647
11-digit product format
586570647
Labeler code
58657
Product ID
58657-647_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
.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, 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
58657-647-01Clonidine Hydrochloride100 in 1 BOTTLETABLET1007
58657-647-10Clonidine Hydrochloride1000 in 1 BOTTLETABLET10007
58657-647-50Clonidine Hydrochloride500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-647-01EA - Each58657-647d16a9c11-c1f4-422e-a538-e030d6c4562112020-09-14
58657-647-10EA - Each58657-64761322acb-f9e1-4e61-8427-6b3723a53aea12022-05-04
58657-647-50EA - Each58657-6470b61af77-4b03-4d94-9e77-8e16e9af0d9912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-647CLONIDINE 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
884173cloNIDine HCl 0.1 MG Oral TabletPSN0f8adf88-26a4-4dd1-bfbb-784a528641e6106
884173clonidine hydrochloride 0.1 MG Oral TabletSCD0f8adf88-26a4-4dd1-bfbb-784a528641e6106
884173clonidine HCl 100 MCG Oral TabletSY0f8adf88-26a4-4dd1-bfbb-784a528641e6106
884173cloNIDine HCl 0.1 MG Oral TabletPSN88c11229-7eed-4fed-983f-503b78f03383105
884173clonidine hydrochloride 0.1 MG Oral TabletSCD88c11229-7eed-4fed-983f-503b78f03383105
884173clonidine HCl 100 MCG Oral TabletSY88c11229-7eed-4fed-983f-503b78f03383105
884173cloNIDine HCl 0.1 MG Oral TabletPSNd2f80661-34c4-42ff-b1c2-3ab8f9d9ef4d102
884173clonidine hydrochloride 0.1 MG Oral TabletSCDd2f80661-34c4-42ff-b1c2-3ab8f9d9ef4d102
884173clonidine HCl 100 MCG Oral TabletSYd2f80661-34c4-42ff-b1c2-3ab8f9d9ef4d102
884173cloNIDine HCl 0.1 MG Oral TabletPSNdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
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 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 TabletSYdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884189clonidine HCl 300 MCG Oral TabletSYdffb5fdd-06c0-4275-9f89-9e12b3adf8a97
884173cloNIDine HCl 0.1 MG Oral TabletPSNd6f7ebb0-e05e-d382-e053-2a95a90a39f21
884173cloNIDine HCl 0.1 MG Oral TabletPSN1c65bafb-9752-4785-84b1-376cf863fd071
884173clonidine hydrochloride 0.1 MG Oral TabletSCDd6f7ebb0-e05e-d382-e053-2a95a90a39f21
884173clonidine hydrochloride 0.1 MG Oral TabletSCD1c65bafb-9752-4785-84b1-376cf863fd071
884173clonidine HCl 100 MCG Oral TabletSYd6f7ebb0-e05e-d382-e053-2a95a90a39f21
884173clonidine HCl 100 MCG Oral TabletSY1c65bafb-9752-4785-84b1-376cf863fd071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-647-0158657064701100 TABLET in 1 BOTTLE (58657-647-01) 100 tablet2020-07-010000-00-00NoNoCurrent
58657-647-10586570647101000 TABLET in 1 BOTTLE (58657-647-10) 1000 tablet2020-07-010000-00-00NoNoCurrent
58657-647-5058657064750500 TABLET in 1 BOTTLE (58657-647-50) 500 tablet2020-07-010000-00-00NoNoCurrent