FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
68180-606
11-digit product format
681800606
Labeler code
68180
Product ID
68180-606_deb39225-24ce-45aa-a32b-bfa70bb8d25b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA209285
Marketing category
ANDA
Marketing start
2018-02-07
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
68180-606-06Clonidine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE309
68180-606-07Clonidine Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE609
68180-606-09Clonidine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-606-07EA - Each68180-60666bf2be7-a520-48e3-92ad-571fb194dfe412018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-606CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 3 package rows20231213_745c8731-63e0-47ce-96d3-6a4d21c655e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013930cloNIDine HCl 0.1 MG 12HR Extended Release Oral TabletPSN745c8731-63e0-47ce-96d3-6a4d21c655e29
101393012 HR clonidine hydrochloride 0.1 MG Extended Release Oral TabletSCD745c8731-63e0-47ce-96d3-6a4d21c655e29
1013930clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral TabletSY745c8731-63e0-47ce-96d3-6a4d21c655e29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-606-066818006060630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-606-06) 2018-02-070000-00-00NoNoCurrent
68180-606-076818006060760 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-606-07) 2018-02-070000-00-00NoNoCurrent
68180-606-096818006060990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-606-09) 2018-02-070000-00-00NoNoCurrent