FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
71335-3028
Requested package NDC
71335-3028-3
11-digit product format
713353028
Labeler code
71335
Product ID
71335-3028_33a25cc7-8de5-46f1-9fc8-702f26faa367
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
a32f4b18-1090-4d79-a56b-39c0cf366bbcAvailable 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
71335-3028-1Clonidine hydrochloride30 in 1 BOTTLETABLET30101
71335-3028-2Clonidine hydrochloride60 in 1 BOTTLETABLET60101
71335-3028-3Clonidine hydrochloride100 in 1 BOTTLETABLET100101
71335-3028-4Clonidine hydrochloride90 in 1 BOTTLETABLET90101
71335-3028-5Clonidine hydrochloride120 in 1 BOTTLETABLET120101
71335-3028-6Clonidine hydrochloride14 in 1 BOTTLETABLET14101
71335-3028-7Clonidine hydrochloride15 in 1 BOTTLETABLET15101
71335-3028-8Clonidine hydrochloride20 in 1 BOTTLETABLET20101

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
ndc (package): 71335-3028-3
ndc (product): 71335-3028
ndc11 (package): 71335302803
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
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 TabletPSNa32f4b18-1090-4d79-a56b-39c0cf366bbc101
884185clonidine hydrochloride 0.2 MG Oral TabletSCDa32f4b18-1090-4d79-a56b-39c0cf366bbc101
884185clonidine HCl 200 MCG Oral TabletSYa32f4b18-1090-4d79-a56b-39c0cf366bbc101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3028-371335302803100 TABLET in 1 BOTTLE (71335-3028-3) 100 tablet2026-02-05NoNoCurrent