FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
71205-829
Requested package NDC
71205-829-90
11-digit product format
712050829
Labeler code
71205
Product ID
71205-829_8427eee0-955d-4718-b259-73dab56d36d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA070924
Marketing category
ANDA
Marketing start
2017-06-01
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.2 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

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W76I6XXF06Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884185Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8427eee0-955d-4718-b259-73dab56d36d2Available on FDA.report

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
71205-829-30Clonidine hydrochloride30 in 1 BOTTLETABLET301
71205-829-60Clonidine hydrochloride60 in 1 BOTTLETABLET601
71205-829-90Clonidine hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-829-30EA - Each71205-829d3498d22-f0da-45e4-b196-a79d5e600d6412023-12-05
71205-829-90EA - Each71205-82965f907eb-4a9f-4fff-a667-6f527afe0b9f12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-829CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20230825_8427eee0-955d-4718-b259-73dab56d36d2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepacka32f4b18-1090-4d79-a56b-39c0cf366bbc2026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070924
application number: ANDA070924
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDENorthwind Health Company, LLCdf77e732-9765-ee5c-e053-2a95a90abc922026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070924
application number: ANDA070924
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEProficient Rx LP8427eee0-955d-4718-b259-73dab56d36d22023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070924
application number: ANDA070924
ndc (package): 71205-829-90
ndc (product): 71205-829
ndc11 (package): 71205082990
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAsclemed USA, Inc.e8c7aa08-1450-de68-e053-2995a90ad0b62022-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070924
application number: ANDA070924

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSN8427eee0-955d-4718-b259-73dab56d36d21
884185clonidine hydrochloride 0.2 MG Oral TabletSCD8427eee0-955d-4718-b259-73dab56d36d21
884185clonidine HCl 200 MCG Oral TabletSY8427eee0-955d-4718-b259-73dab56d36d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-829-907120508299090 TABLET in 1 BOTTLE (71205-829-90) 90 tablet2023-08-18NoNoCurrent