FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
29300-137
11-digit product format
293000137
Labeler code
29300
Product ID
29300-137_d015993c-74da-4faa-9e51-727d6d93a867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA078895
Marketing category
ANDA
Marketing start
2009-09-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2027-12-31

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
29300-137-01clonidine hydrochloride100 in 1 BOTTLE, PLASTICTABLET10011
29300-137-05clonidine hydrochloride500 in 1 BOTTLE, PLASTICTABLET50011
29300-137-10clonidine hydrochloride1000 in 1 BOTTLE, PLASTICTABLET100011
29300-137-25clonidine hydrochloride2500 in 1 BOTTLE, PLASTICTABLET250011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-137-01EA - Each29300-137d433c77f-0426-4214-98c9-439c10d0385112012-07-24
29300-137-05EA - Each29300-137a06f1842-6172-4eba-a6fb-9e699ba8674012015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQCLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-137CLONIDINE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]9Current NDC, Legacy NDC, 4 package rows20201230_21bfa28f-20df-43fd-bb80-b720d3b40696.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185cloNIDine HCl 0.2 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189cloNIDine HCl 0.3 MG Oral TabletPSN70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884173clonidine hydrochloride 0.1 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185clonidine hydrochloride 0.2 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189clonidine hydrochloride 0.3 MG Oral TabletSCD70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884173clonidine HCl 100 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884185clonidine HCl 200 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189clonidine HCl 300 MCG Oral TabletSY70c0c9f4-075d-4621-ae13-e8f03d814d5f30
884189cloNIDine HCl 0.3 MG Oral TabletPSNbe1b921d-152e-4bd5-82bd-56e2f8beef3e16
884189clonidine hydrochloride 0.3 MG Oral TabletSCDbe1b921d-152e-4bd5-82bd-56e2f8beef3e16
884189clonidine HCl 300 MCG Oral TabletSYbe1b921d-152e-4bd5-82bd-56e2f8beef3e16
884189cloNIDine HCl 0.3 MG Oral TabletPSNf6eecd83-f607-47db-ae92-0127e345046214
884189clonidine hydrochloride 0.3 MG Oral TabletSCDf6eecd83-f607-47db-ae92-0127e345046214
884189clonidine HCl 300 MCG Oral TabletSYf6eecd83-f607-47db-ae92-0127e345046214
884173cloNIDine HCl 0.1 MG Oral TabletPSN21bfa28f-20df-43fd-bb80-b720d3b4069611
884185cloNIDine HCl 0.2 MG Oral TabletPSN21bfa28f-20df-43fd-bb80-b720d3b4069611
884189cloNIDine HCl 0.3 MG Oral TabletPSN21bfa28f-20df-43fd-bb80-b720d3b4069611
884173clonidine hydrochloride 0.1 MG Oral TabletSCD21bfa28f-20df-43fd-bb80-b720d3b4069611
884185clonidine hydrochloride 0.2 MG Oral TabletSCD21bfa28f-20df-43fd-bb80-b720d3b4069611
884189clonidine hydrochloride 0.3 MG Oral TabletSCD21bfa28f-20df-43fd-bb80-b720d3b4069611
884173clonidine HCl 100 MCG Oral TabletSY21bfa28f-20df-43fd-bb80-b720d3b4069611
884185clonidine HCl 200 MCG Oral TabletSY21bfa28f-20df-43fd-bb80-b720d3b4069611
884189clonidine HCl 300 MCG Oral TabletSY21bfa28f-20df-43fd-bb80-b720d3b4069611
884189cloNIDine HCl 0.3 MG Oral TabletPSNe96ab74c-eedf-4d71-8a35-d5ec3daa75929
884189clonidine hydrochloride 0.3 MG Oral TabletSCDe96ab74c-eedf-4d71-8a35-d5ec3daa75929
884189clonidine HCl 300 MCG Oral TabletSYe96ab74c-eedf-4d71-8a35-d5ec3daa75929
884173cloNIDine HCl 0.1 MG Oral TabletPSN2823a922-3217-6062-e054-00144ff88e884
884189cloNIDine HCl 0.3 MG Oral TabletPSN415b168c-1267-2777-e054-00144ff88e884
884189cloNIDine HCl 0.3 MG Oral TabletPSNab2ffb6e-7070-063b-e053-2a95a90aff224
884189cloNIDine HCl 0.3 MG Oral TabletPSN2823a922-3217-6062-e054-00144ff88e884
884173clonidine hydrochloride 0.1 MG Oral TabletSCD2823a922-3217-6062-e054-00144ff88e884
884189clonidine hydrochloride 0.3 MG Oral TabletSCD415b168c-1267-2777-e054-00144ff88e884
884189clonidine hydrochloride 0.3 MG Oral TabletSCDab2ffb6e-7070-063b-e053-2a95a90aff224
884189clonidine hydrochloride 0.3 MG Oral TabletSCD2823a922-3217-6062-e054-00144ff88e884
884173clonidine HCl 100 MCG Oral TabletSY2823a922-3217-6062-e054-00144ff88e884
884189clonidine HCl 300 MCG Oral TabletSY2823a922-3217-6062-e054-00144ff88e884
884189clonidine HCl 300 MCG Oral TabletSYab2ffb6e-7070-063b-e053-2a95a90aff224
884189clonidine HCl 300 MCG Oral TabletSY415b168c-1267-2777-e054-00144ff88e884
884173cloNIDine HCl 0.1 MG Oral TabletPSNfcebe343-18ad-d4cd-e053-6294a90a72d52
884173cloNIDine HCl 0.1 MG Oral TabletPSN200afa03-adf3-4dca-8de8-1569701bd0292
884185cloNIDine HCl 0.2 MG Oral TabletPSNfcebe343-18ad-d4cd-e053-6294a90a72d52
884185cloNIDine HCl 0.2 MG Oral TabletPSN200afa03-adf3-4dca-8de8-1569701bd0292
884189cloNIDine HCl 0.3 MG Oral TabletPSNfcebe343-18ad-d4cd-e053-6294a90a72d52
884189cloNIDine HCl 0.3 MG Oral TabletPSN200afa03-adf3-4dca-8de8-1569701bd0292
884189cloNIDine HCl 0.3 MG Oral TabletPSN62f926a8-3359-47f2-afcc-b866e43437932
884173clonidine hydrochloride 0.1 MG Oral TabletSCDfcebe343-18ad-d4cd-e053-6294a90a72d52
884173clonidine hydrochloride 0.1 MG Oral TabletSCD200afa03-adf3-4dca-8de8-1569701bd0292
884185clonidine hydrochloride 0.2 MG Oral TabletSCDfcebe343-18ad-d4cd-e053-6294a90a72d52
884185clonidine hydrochloride 0.2 MG Oral TabletSCD200afa03-adf3-4dca-8de8-1569701bd0292
884189clonidine hydrochloride 0.3 MG Oral TabletSCDfcebe343-18ad-d4cd-e053-6294a90a72d52
884189clonidine hydrochloride 0.3 MG Oral TabletSCD200afa03-adf3-4dca-8de8-1569701bd0292
884189clonidine hydrochloride 0.3 MG Oral TabletSCD62f926a8-3359-47f2-afcc-b866e43437932
884173clonidine HCl 100 MCG Oral TabletSY200afa03-adf3-4dca-8de8-1569701bd0292
884173clonidine HCl 100 MCG Oral TabletSYfcebe343-18ad-d4cd-e053-6294a90a72d52
884185clonidine HCl 200 MCG Oral TabletSYfcebe343-18ad-d4cd-e053-6294a90a72d52
884185clonidine HCl 200 MCG Oral TabletSY200afa03-adf3-4dca-8de8-1569701bd0292
884189clonidine HCl 300 MCG Oral TabletSY62f926a8-3359-47f2-afcc-b866e43437932
884189clonidine HCl 300 MCG Oral TabletSY200afa03-adf3-4dca-8de8-1569701bd0292
884189clonidine HCl 300 MCG Oral TabletSYfcebe343-18ad-d4cd-e053-6294a90a72d52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-137-0129300013701100 TABLET in 1 BOTTLE, PLASTIC (29300-137-01) 100 tablet2009-09-210000-00-00NoNoCurrent
29300-137-0529300013705500 TABLET in 1 BOTTLE, PLASTIC (29300-137-05) 500 tablet2009-09-210000-00-00NoNoCurrent
29300-137-10293000137101000 TABLET in 1 BOTTLE, PLASTIC (29300-137-10) 1000 tablet2009-09-210000-00-00NoNoCurrent
29300-137-25293000137252500 TABLET in 1 BOTTLE, PLASTIC (29300-137-25) 2500 tablet2009-09-210000-00-00NoNoCurrent