FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
58657-649
11-digit product format
586570649
Labeler code
58657
Product ID
58657-649_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
.3 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.3 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
58657-649-01Clonidine Hydrochloride100 in 1 BOTTLETABLET1007
58657-649-10Clonidine Hydrochloride1000 in 1 BOTTLETABLET10007
58657-649-50Clonidine Hydrochloride500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-649-01EA - Each58657-649a0c21ad9-f9fd-4144-b9eb-b51357b9aa5f12020-09-14
58657-649-10EA - Each58657-649e067e2af-0bdf-4be4-b166-ff39db978ab312022-05-04
58657-649-50EA - Each58657-64983b6e659-0b65-49e7-814f-ac3304a0f01f12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-649CLONIDINE 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
884189cloNIDine HCl 0.3 MG Oral TabletPSN1df79865-c028-45c7-8580-9908eec80979107
884189clonidine hydrochloride 0.3 MG Oral TabletSCD1df79865-c028-45c7-8580-9908eec80979107
884189clonidine HCl 300 MCG Oral TabletSY1df79865-c028-45c7-8580-9908eec80979107
884189cloNIDine HCl 0.3 MG Oral TabletPSN029ed62c-67cb-406f-84e4-702aebfa7d68106
884189clonidine hydrochloride 0.3 MG Oral TabletSCD029ed62c-67cb-406f-84e4-702aebfa7d68106
884189clonidine HCl 300 MCG Oral TabletSY029ed62c-67cb-406f-84e4-702aebfa7d68106
884189cloNIDine HCl 0.3 MG Oral TabletPSN849cafb5-0a98-4434-80bb-b16e7109dd06105
884189clonidine hydrochloride 0.3 MG Oral TabletSCD849cafb5-0a98-4434-80bb-b16e7109dd06105
884189clonidine HCl 300 MCG Oral TabletSY849cafb5-0a98-4434-80bb-b16e7109dd06105
884189cloNIDine HCl 0.3 MG Oral TabletPSN075b6261-9064-41da-b5e0-0959767e0d9a102
884189clonidine hydrochloride 0.3 MG Oral TabletSCD075b6261-9064-41da-b5e0-0959767e0d9a102
884189clonidine HCl 300 MCG Oral TabletSY075b6261-9064-41da-b5e0-0959767e0d9a102
884189cloNIDine HCl 0.3 MG Oral TabletPSN60171b1d-03af-4849-a030-6260192b11ce100
884189clonidine hydrochloride 0.3 MG Oral TabletSCD60171b1d-03af-4849-a030-6260192b11ce100
884189clonidine HCl 300 MCG Oral TabletSY60171b1d-03af-4849-a030-6260192b11ce100
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
884189cloNIDine HCl 0.3 MG Oral TabletPSN6d7cfb02-e580-4658-a2fe-2149b515d4341
884189clonidine hydrochloride 0.3 MG Oral TabletSCD6d7cfb02-e580-4658-a2fe-2149b515d4341
884189clonidine HCl 300 MCG Oral TabletSY6d7cfb02-e580-4658-a2fe-2149b515d4341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-649-0158657064901100 TABLET in 1 BOTTLE (58657-649-01) 100 tablet2020-07-010000-00-00NoNoCurrent
58657-649-10586570649101000 TABLET in 1 BOTTLE (58657-649-10) 1000 tablet2020-07-010000-00-00NoNoCurrent
58657-649-5058657064950500 TABLET in 1 BOTTLE (58657-649-50) 500 tablet2020-07-010000-00-00NoNoCurrent