clonidine hydrochloride

Product NDC
63187-419
11-digit product format
631870419
Labeler code
63187
Product ID
63187-419_f2f79854-3160-43e7-8676-9d1b7d2970c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078895
Marketing category
ANDA
Marketing start
2009-09-21
Marketing end
0000-00-00
Substance
CLONIDINE HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-419-12EA - Each63187-419d3a4d71c-c1a9-4376-bb56-cda160abec2c12021-06-02
63187-419-20EA - Each63187-4191bc233d1-0cb9-46b2-8be5-089ed5d198a812019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQCLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-419CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]6Legacy NDC20210330_94ee4b8c-fc87-4547-85ee-6c3fce3cdc95.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-419-126318704191212 TABLET in 1 BOTTLE, PLASTIC (63187-419-12) 12 tablet2021-03-240000-00-00NoNoCurrent
63187-419-206318704192020 TABLET in 1 BOTTLE, PLASTIC (63187-419-20) 20 tablet2019-02-010000-00-00NoNoCurrent
63187-419-306318704193030 TABLET in 1 BOTTLE, PLASTIC (63187-419-30) 30 tablet2019-02-010000-00-00NoNoCurrent
63187-419-606318704196060 TABLET in 1 BOTTLE, PLASTIC (63187-419-60) 60 tablet2019-02-010000-00-00NoNoCurrent
63187-419-906318704199090 TABLET in 1 BOTTLE, PLASTIC (63187-419-90) 90 tablet2019-02-010000-00-00NoNoCurrent