FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
60687-462
11-digit product format
606870462
Labeler code
60687
Product ID
60687-462_1a9e9967-92e8-a001-e063-6394a90a0204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209686
Marketing category
ANDA
Marketing start
2019-12-17
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
60687-462-11Clonidine hydrochloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE14
60687-462-21Clonidine hydrochloride30 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-462CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20240612_95b390cc-0578-4cb0-9c08-4853388b2ec9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN95b390cc-0578-4cb0-9c08-4853388b2ec94
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD95b390cc-0578-4cb0-9c08-4853388b2ec94
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY95b390cc-0578-4cb0-9c08-4853388b2ec94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-462-11606870462111 in 1 BLISTER PACKHistorical
60687-462-216068704622130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-462-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-462-11) 30 blister pack2019-12-170000-00-00NoNoCurrent