FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
52817-181
11-digit product format
528170181
Labeler code
52817
Product ID
52817-181_4feb108f-0b2f-75d1-e063-6394a90a6152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
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.

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884173Internal RxNorm lookup
884185Internal RxNorm lookup
884189Internal RxNorm lookup
2740803Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c83e4e4f-bd0e-449d-958a-dc0d570a01baAvailable 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
52817-181-00Clonidine hydrochloride1000 in 1 BOTTLETABLET100010
52817-181-10Clonidine hydrochloride100 in 1 BOTTLETABLET10010
52817-181-50Clonidine hydrochloride500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-181-00EA - Each52817-18130fcb1f4-8f7f-4e29-9d51-5c4c4b71a8d012017-07-07
52817-181-10EA - Each52817-1810469f33a-91d8-4b03-92b3-0f7911130fb712017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-181CLONIDINE HYDROCHLORIDE TABLET [TRUPHARMA, LLC]7Current NDC, Legacy NDC, 3 package rows20250102_c83e4e4f-bd0e-449d-958a-dc0d570a01ba.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDETruPharma, LLCc83e4e4f-bd0e-449d-958a-dc0d570a01ba2026-04-30Warnings, Adverse reactionsExact identifier
ndc (product): 52817-181
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
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
884173cloNIDine HCl 0.1 MG Oral TabletPSNc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884185cloNIDine HCl 0.2 MG Oral TabletPSNc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884189cloNIDine HCl 0.3 MG Oral TabletPSNc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
2740803cloNIDine hydrochloride 0.05 MG Oral TabletPSNc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
2740803clonidine hydrochloride 0.05 MG Oral TabletSCDc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884173clonidine hydrochloride 0.1 MG Oral TabletSCDc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884185clonidine hydrochloride 0.2 MG Oral TabletSCDc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884189clonidine hydrochloride 0.3 MG Oral TabletSCDc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884173clonidine HCl 100 MCG Oral TabletSYc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884185clonidine HCl 200 MCG Oral TabletSYc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884189clonidine HCl 300 MCG Oral TabletSYc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
2740803clonidine hydrochloride 50 MCG Oral TabletSYc83e4e4f-bd0e-449d-958a-dc0d570a01ba10
884185cloNIDine HCl 0.2 MG Oral TabletPSNdf77e732-9765-ee5c-e053-2a95a90abc923
884185clonidine hydrochloride 0.2 MG Oral TabletSCDdf77e732-9765-ee5c-e053-2a95a90abc923
884185clonidine HCl 200 MCG Oral TabletSYdf77e732-9765-ee5c-e053-2a95a90abc923
884173cloNIDine HCl 0.1 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884185cloNIDine HCl 0.2 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884185cloNIDine HCl 0.2 MG Oral TabletPSN8427eee0-955d-4718-b259-73dab56d36d21
884189cloNIDine HCl 0.3 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884185clonidine hydrochloride 0.2 MG Oral TabletSCD8427eee0-955d-4718-b259-73dab56d36d21
884185clonidine hydrochloride 0.2 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884189clonidine hydrochloride 0.3 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
884173clonidine HCl 100 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61
884185clonidine HCl 200 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61
884185clonidine HCl 200 MCG Oral TabletSY8427eee0-955d-4718-b259-73dab56d36d21
884189clonidine HCl 300 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-181-00528170181001000 TABLET in 1 BOTTLE (52817-181-00) 1000 tablet2017-06-010000-00-00NoNoCurrent
52817-181-1052817018110100 TABLET in 1 BOTTLE (52817-181-10) 100 tablet2017-06-010000-00-00NoNoCurrent
52817-181-5052817018150500 TABLET in 1 BOTTLE (52817-181-50) 500 tablet2017-06-010000-00-00NoNoCurrent