FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
68071-3987
Requested package NDC
68071-3987-1
11-digit product format
680713987
Labeler code
68071
Product ID
68071-3987_50c8b0f6-02fe-4729-e063-6394a90a624c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
50c8a725-a449-256b-e063-6294a90a3e44Available 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
68071-3987-1Clonidine hydrochloride100 in 1 BOTTLETABLET1001

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
ndc (package): 68071-3987-1
ndc (product): 68071-3987
ndc11 (package): 68071398701
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 TabletPSN50c8a725-a449-256b-e063-6294a90a3e441
884173clonidine hydrochloride 0.1 MG Oral TabletSCD50c8a725-a449-256b-e063-6294a90a3e441
884173clonidine HCl 100 MCG Oral TabletSY50c8a725-a449-256b-e063-6294a90a3e441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3987-168071398701100 TABLET in 1 BOTTLE (68071-3987-1) 100 tablet2026-05-01NoNoCurrent