FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
71205-588
Requested package NDC
71205-588-12
11-digit product format
712050588
Labeler code
71205
Product ID
71205-588_63ed2151-a687-4972-bbe7-f1f1ec060659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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.

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.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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33c68d5e-6a68-40fd-a326-bf36a7e01d5bAvailable 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
71205-588-12Clonidine hydrochloride12 in 1 BOTTLETABLET122
71205-588-30Clonidine hydrochloride30 in 1 BOTTLETABLET302
71205-588-60Clonidine hydrochloride60 in 1 BOTTLETABLET602
71205-588-90Clonidine hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-588-12EA - Each71205-5887e09ae77-6ae3-420a-8546-2b43e214f0de12021-10-08
71205-588-30EA - Each71205-58866bb21c9-0b8a-4e68-80f6-ad97d394f22112022-12-07
71205-588-60EA - Each71205-588615f1b6d-2b2f-496f-ab1d-7d5837681e7512026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-588CLONIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20220930_33c68d5e-6a68-40fd-a326-bf36a7e01d5b.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 · 7 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 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
ndc (package): 71205-588-12
ndc (product): 71205-588
ndc11 (package): 71205058812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-588-127120505881212 TABLET in 1 BOTTLE (71205-588-12) 12 tablet2021-07-070000-00-00NoNoCurrent