FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
29300-468
11-digit product format
293000468
Labeler code
29300
Product ID
29300-468_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
2020-12-24
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
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.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
29300-468-01clonidine hydrochloride100 in 1 BOTTLE, PLASTICTABLET10011
29300-468-05clonidine hydrochloride500 in 1 BOTTLE, PLASTICTABLET50011
29300-468-10clonidine hydrochloride1000 in 1 BOTTLE, PLASTICTABLET100011
29300-468-50clonidine hydrochloride5000 in 1 BOTTLE, PLASTICTABLET500011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-468-01EA - Each29300-46898f1f067-f8b2-47bd-b6fd-63afb00a45d112021-04-08
29300-468-05EA - Each29300-468f45ac6b0-545d-4eb8-9ef2-f8181186b66612021-03-02
29300-468-10EA - Each29300-4683669437c-f642-47b4-acc8-992ab28f136412021-02-05

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
29300-468CLONIDINE 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 TabletPSN893a6cf5-d34e-4971-b132-3f5138e481ce100
884173clonidine hydrochloride 0.1 MG Oral TabletSCD893a6cf5-d34e-4971-b132-3f5138e481ce100
884173clonidine HCl 100 MCG Oral TabletSY893a6cf5-d34e-4971-b132-3f5138e481ce100
884173cloNIDine HCl 0.1 MG Oral TabletPSNc5c85b76-4d5c-47f0-bafb-31efe1fbaed331
884173clonidine hydrochloride 0.1 MG Oral TabletSCDc5c85b76-4d5c-47f0-bafb-31efe1fbaed331
884173clonidine HCl 100 MCG Oral TabletSYc5c85b76-4d5c-47f0-bafb-31efe1fbaed331
884173cloNIDine HCl 0.1 MG Oral TabletPSN22fbd302-46b5-4bdc-87e2-fda94cb2253029
884173clonidine hydrochloride 0.1 MG Oral TabletSCD22fbd302-46b5-4bdc-87e2-fda94cb2253029
884173clonidine HCl 100 MCG Oral TabletSY22fbd302-46b5-4bdc-87e2-fda94cb2253029
884173cloNIDine HCl 0.1 MG Oral TabletPSN9d889b1c-9599-44fa-9e47-6261fbf2837e26
884173clonidine hydrochloride 0.1 MG Oral TabletSCD9d889b1c-9599-44fa-9e47-6261fbf2837e26
884173clonidine HCl 100 MCG Oral TabletSY9d889b1c-9599-44fa-9e47-6261fbf2837e26
884173cloNIDine HCl 0.1 MG Oral TabletPSNe5d24f52-e0c2-428d-b647-481d63ffd95f15
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe5d24f52-e0c2-428d-b647-481d63ffd95f15
884173clonidine HCl 100 MCG Oral TabletSYe5d24f52-e0c2-428d-b647-481d63ffd95f15
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 TabletPSN55ab721b-7b4c-42d5-99e3-745008fe139c4
884173clonidine hydrochloride 0.1 MG Oral TabletSCD55ab721b-7b4c-42d5-99e3-745008fe139c4
884173clonidine HCl 100 MCG Oral TabletSY55ab721b-7b4c-42d5-99e3-745008fe139c4
884173cloNIDine HCl 0.1 MG Oral TabletPSN1ab3b82f-db7f-22bf-e063-6294a90ae93f3
884173clonidine hydrochloride 0.1 MG Oral TabletSCD1ab3b82f-db7f-22bf-e063-6294a90ae93f3
884173clonidine HCl 100 MCG Oral TabletSY1ab3b82f-db7f-22bf-e063-6294a90ae93f3
884173cloNIDine HCl 0.1 MG Oral TabletPSN32d72d7b-5881-f431-e063-6394a90a35472
884173cloNIDine HCl 0.1 MG Oral TabletPSN200afa03-adf3-4dca-8de8-1569701bd0292
884173cloNIDine HCl 0.1 MG Oral TabletPSN38680c1d-3929-40d5-bda9-4eea5693afca2
884173cloNIDine HCl 0.1 MG Oral TabletPSNfcebe343-18ad-d4cd-e053-6294a90a72d52
884173cloNIDine HCl 0.1 MG Oral TabletPSN300b4437-74b3-119b-e063-6394a90a0d0f2
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
884173clonidine hydrochloride 0.1 MG Oral TabletSCDfcebe343-18ad-d4cd-e053-6294a90a72d52
884173clonidine hydrochloride 0.1 MG Oral TabletSCD300b4437-74b3-119b-e063-6394a90a0d0f2
884173clonidine hydrochloride 0.1 MG Oral TabletSCD38680c1d-3929-40d5-bda9-4eea5693afca2
884173clonidine hydrochloride 0.1 MG Oral TabletSCD32d72d7b-5881-f431-e063-6394a90a35472
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
884173clonidine HCl 100 MCG Oral TabletSYfcebe343-18ad-d4cd-e053-6294a90a72d52
884173clonidine HCl 100 MCG Oral TabletSY32d72d7b-5881-f431-e063-6394a90a35472
884173clonidine HCl 100 MCG Oral TabletSY38680c1d-3929-40d5-bda9-4eea5693afca2
884173clonidine HCl 100 MCG Oral TabletSY300b4437-74b3-119b-e063-6394a90a0d0f2
884173clonidine HCl 100 MCG Oral TabletSY200afa03-adf3-4dca-8de8-1569701bd0292
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
884173cloNIDine HCl 0.1 MG Oral TabletPSN427939a4-6bbf-0d80-e063-6294a90aa2a01
884173cloNIDine HCl 0.1 MG Oral TabletPSN29657015-e865-56a7-e063-6394a90af6df1
884173clonidine hydrochloride 0.1 MG Oral TabletSCD427939a4-6bbf-0d80-e063-6294a90aa2a01
884173clonidine hydrochloride 0.1 MG Oral TabletSCD29657015-e865-56a7-e063-6394a90af6df1
884173clonidine HCl 100 MCG Oral TabletSY427939a4-6bbf-0d80-e063-6294a90aa2a01
884173clonidine HCl 100 MCG Oral TabletSY29657015-e865-56a7-e063-6394a90af6df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-468-0129300046801100 TABLET in 1 BOTTLE, PLASTIC (29300-468-01) 100 tablet2020-12-240000-00-00NoNoCurrent
29300-468-0529300046805500 TABLET in 1 BOTTLE, PLASTIC (29300-468-05) 500 tablet2020-12-240000-00-00NoNoCurrent
29300-468-10293000468101000 TABLET in 1 BOTTLE, PLASTIC (29300-468-10) 1000 tablet2020-12-240000-00-00NoNoCurrent
29300-468-50293000468505000 TABLET in 1 BOTTLE, PLASTIC (29300-468-50) 5000 tablet2020-12-240000-00-00NoNoCurrent