FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
29300-136
11-digit product format
293000136
Labeler code
29300
Product ID
29300-136_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
.2 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.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
29300-136-01clonidine hydrochloride100 in 1 BOTTLE, PLASTICTABLET10011
29300-136-05clonidine hydrochloride500 in 1 BOTTLE, PLASTICTABLET50011
29300-136-10clonidine hydrochloride1000 in 1 BOTTLE, PLASTICTABLET100011
29300-136-50clonidine hydrochloride5000 in 1 BOTTLE, PLASTICTABLET500011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-136-01EA - Each29300-136b135bfc8-fccc-4e9c-8f0c-cd1d2eb1101812012-07-24
29300-136-05EA - Each29300-136c64b149a-506d-471c-8635-142cdca3493712015-01-05
29300-136-10EA - Each29300-13645eb0d17-4e85-47b4-aaa8-d5c6babfa9b412013-02-13

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
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQCLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-136CLONIDINE 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
884185cloNIDine HCl 0.2 MG Oral TabletPSN67a6d531-3a00-4887-8539-3dd17b8fdbfb100
884185clonidine hydrochloride 0.2 MG Oral TabletSCD67a6d531-3a00-4887-8539-3dd17b8fdbfb100
884185clonidine HCl 200 MCG Oral TabletSY67a6d531-3a00-4887-8539-3dd17b8fdbfb100
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
884185cloNIDine HCl 0.2 MG Oral TabletPSNea1527a5-4939-4ff7-a827-f88a9113a07d15
884185clonidine hydrochloride 0.2 MG Oral TabletSCDea1527a5-4939-4ff7-a827-f88a9113a07d15
884185clonidine HCl 200 MCG Oral TabletSYea1527a5-4939-4ff7-a827-f88a9113a07d15
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
884173cloNIDine HCl 0.1 MG Oral TabletPSNe938a4ed-9f7f-48bb-b7a4-b0784496e8607
884185cloNIDine HCl 0.2 MG Oral TabletPSNe938a4ed-9f7f-48bb-b7a4-b0784496e8607
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe938a4ed-9f7f-48bb-b7a4-b0784496e8607
884185clonidine hydrochloride 0.2 MG Oral TabletSCDe938a4ed-9f7f-48bb-b7a4-b0784496e8607
884173clonidine HCl 100 MCG Oral TabletSYe938a4ed-9f7f-48bb-b7a4-b0784496e8607
884185clonidine HCl 200 MCG Oral TabletSYe938a4ed-9f7f-48bb-b7a4-b0784496e8607
884185cloNIDine HCl 0.2 MG Oral TabletPSN26dc28bb-2a2e-62d6-e054-00144ff8d46c4
884185clonidine hydrochloride 0.2 MG Oral TabletSCD26dc28bb-2a2e-62d6-e054-00144ff8d46c4
884185clonidine HCl 200 MCG Oral TabletSY26dc28bb-2a2e-62d6-e054-00144ff8d46c4
884185cloNIDine HCl 0.2 MG Oral TabletPSN3e0c4b95-eb03-2465-e054-00144ff88e883
884185clonidine hydrochloride 0.2 MG Oral TabletSCD3e0c4b95-eb03-2465-e054-00144ff88e883
884185clonidine HCl 200 MCG Oral TabletSY3e0c4b95-eb03-2465-e054-00144ff88e883
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
884185cloNIDine HCl 0.2 MG Oral TabletPSNc812012c-4b1d-40a4-8d4e-aaae2bf1c8522
884189cloNIDine HCl 0.3 MG Oral TabletPSNfcebe343-18ad-d4cd-e053-6294a90a72d52
884189cloNIDine HCl 0.3 MG Oral TabletPSN200afa03-adf3-4dca-8de8-1569701bd0292
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 TabletSCDc812012c-4b1d-40a4-8d4e-aaae2bf1c8522
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 TabletSCD200afa03-adf3-4dca-8de8-1569701bd0292
884189clonidine hydrochloride 0.3 MG Oral TabletSCDfcebe343-18ad-d4cd-e053-6294a90a72d52
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 TabletSYc812012c-4b1d-40a4-8d4e-aaae2bf1c8522
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 TabletSY200afa03-adf3-4dca-8de8-1569701bd0292
884189clonidine HCl 300 MCG Oral TabletSYfcebe343-18ad-d4cd-e053-6294a90a72d52
884185cloNIDine HCl 0.2 MG Oral TabletPSN5c7f5edd-10b1-49e8-b6ee-23f412caaa8f1
884185clonidine hydrochloride 0.2 MG Oral TabletSCD5c7f5edd-10b1-49e8-b6ee-23f412caaa8f1
884185clonidine HCl 200 MCG Oral TabletSY5c7f5edd-10b1-49e8-b6ee-23f412caaa8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-136-0129300013601100 TABLET in 1 BOTTLE, PLASTIC (29300-136-01) 100 tablet2009-09-210000-00-00NoNoCurrent
29300-136-0529300013605500 TABLET in 1 BOTTLE, PLASTIC (29300-136-05) 500 tablet2009-09-210000-00-00NoNoCurrent
29300-136-10293000136101000 TABLET in 1 BOTTLE, PLASTIC (29300-136-10) 1000 tablet2009-09-210000-00-00NoNoCurrent
29300-136-50293000136505000 TABLET in 1 BOTTLE, PLASTIC (29300-136-50) 5000 tablet2009-09-210000-00-00NoNoCurrent