FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
68001-568
11-digit product format
680010568
Labeler code
68001
Product ID
68001-568_3c4f16d2-af44-ddf6-e063-6294a90aae36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA209686
Marketing category
ANDA
Marketing start
2023-08-24
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui1013930

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
68001-568-06Clonidine hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-568-06EA - Each68001-568b21652e8-4030-459a-86df-553b4895bd0512023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-568CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3Current NDC, 1 package rows20230906_f34ae077-4ace-4e0a-bc87-d559b1c5bf2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSNf34ae077-4ace-4e0a-bc87-d559b1c5bf2f4
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCDf34ae077-4ace-4e0a-bc87-d559b1c5bf2f4
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSYf34ae077-4ace-4e0a-bc87-d559b1c5bf2f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-568-066800105680660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-568-06) 2023-08-24NoNoCurrent