FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
52817-180
11-digit product format
528170180
Labeler code
52817
Product ID
52817-180_4feb108f-0b2f-75d1-e063-6394a90a6152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA070925
Marketing category
ANDA
Marketing start
2017-06-01
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
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.1 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
52817-180-00Clonidine hydrochloride1000 in 1 BOTTLETABLET100010
52817-180-10Clonidine hydrochloride100 in 1 BOTTLETABLET10010
52817-180-50Clonidine hydrochloride500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-180-00EA - Each52817-18054229f5a-91a3-4446-9384-04a37321508b12017-07-07
52817-180-10EA - Each52817-1806aa59267-86a8-46e0-b87a-384d92700a0712017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-180CLONIDINE 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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackcee049ea-a476-433c-971f-2466a6a3263b2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070925
application number: ANDA070925
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.50c8a725-a449-256b-e063-6294a90a3e442026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070925
application number: ANDA070925
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDETruPharma, LLCc83e4e4f-bd0e-449d-958a-dc0d570a01ba2026-04-30Warnings, Adverse reactionsExact identifier
ndc (product): 52817-180
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7484e8fa-13a7-70e9-e053-2a91aa0a24b72026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070925
application number: ANDA070925
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDENorthwind Health Company, LLCdf603f27-d341-3957-e053-2995a90a825f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070925
application number: ANDA070925
CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEProficient Rx LPd072d601-b3d2-46e0-af1f-98adc9572f4a2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070925
application number: ANDA070925
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAsclemed USA, Inc.e8c7aa08-1450-de68-e053-2995a90ad0b62022-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070925
application number: ANDA070925
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEProficient Rx LP33c68d5e-6a68-40fd-a326-bf36a7e01d5b2022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070925
application number: ANDA070925

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
884173cloNIDine HCl 0.1 MG Oral TabletPSNcee049ea-a476-433c-971f-2466a6a3263b5
884173cloNIDine HCl 0.1 MG Oral TabletPSN7484e8fa-13a7-70e9-e053-2a91aa0a24b75
884173clonidine hydrochloride 0.1 MG Oral TabletSCD7484e8fa-13a7-70e9-e053-2a91aa0a24b75
884173clonidine hydrochloride 0.1 MG Oral TabletSCDcee049ea-a476-433c-971f-2466a6a3263b5
884173clonidine HCl 100 MCG Oral TabletSY7484e8fa-13a7-70e9-e053-2a91aa0a24b75
884173clonidine HCl 100 MCG Oral TabletSYcee049ea-a476-433c-971f-2466a6a3263b5
884173cloNIDine HCl 0.1 MG Oral TabletPSNdf603f27-d341-3957-e053-2995a90a825f3
884173clonidine hydrochloride 0.1 MG Oral TabletSCDdf603f27-d341-3957-e053-2995a90a825f3
884173clonidine HCl 100 MCG Oral TabletSYdf603f27-d341-3957-e053-2995a90a825f3
884173cloNIDine HCl 0.1 MG Oral TabletPSN33c68d5e-6a68-40fd-a326-bf36a7e01d5b2
884173clonidine hydrochloride 0.1 MG Oral TabletSCD33c68d5e-6a68-40fd-a326-bf36a7e01d5b2
884173clonidine HCl 100 MCG Oral TabletSY33c68d5e-6a68-40fd-a326-bf36a7e01d5b2
884173cloNIDine HCl 0.1 MG Oral TabletPSN50c8a725-a449-256b-e063-6294a90a3e441
884173cloNIDine HCl 0.1 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884185cloNIDine HCl 0.2 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884189cloNIDine HCl 0.3 MG Oral TabletPSNe8c7aa08-1450-de68-e053-2995a90ad0b61
884173clonidine hydrochloride 0.1 MG Oral TabletSCD50c8a725-a449-256b-e063-6294a90a3e441
884173clonidine hydrochloride 0.1 MG Oral TabletSCDe8c7aa08-1450-de68-e053-2995a90ad0b61
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 TabletSY50c8a725-a449-256b-e063-6294a90a3e441
884173clonidine HCl 100 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61
884185clonidine HCl 200 MCG Oral TabletSYe8c7aa08-1450-de68-e053-2995a90ad0b61
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
52817-180-00528170180001000 TABLET in 1 BOTTLE (52817-180-00) 1000 tablet2017-06-010000-00-00NoNoCurrent
52817-180-1052817018010100 TABLET in 1 BOTTLE (52817-180-10) 100 tablet2017-06-010000-00-00NoNoCurrent
52817-180-5052817018050500 TABLET in 1 BOTTLE (52817-180-50) 500 tablet2017-06-010000-00-00NoNoCurrent