FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
68071-3625
11-digit product format
680713625
Labeler code
68071
Product ID
68071-3625_48477ca1-1a3e-1d01-e063-6394a90a2cb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,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

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
68071-3625-2clonidine hydrochloride120 in 1 BOTTLE, PLASTICTABLET1203
68071-3625-3clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET303
68071-3625-6clonidine hydrochloride60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3625CLONIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 3 package rows20240915_1ab3b82f-db7f-22bf-e063-6294a90ae93f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3625-268071362502120 TABLET in 1 BOTTLE, PLASTIC (68071-3625-2) 120 tablet2026-01-13NoNoHistorical
68071-3625-36807136250330 TABLET in 1 BOTTLE, PLASTIC (68071-3625-3) 30 tablet2024-06-12NoNoHistorical
68071-3625-66807136250660 TABLET in 1 BOTTLE, PLASTIC (68071-3625-6) 60 tablet2024-09-13NoNoHistorical