FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
71335-0922
Requested package NDC
71335-0922-6
11-digit product format
713350922
Labeler code
71335
Product ID
71335-0922_1a487aeb-d565-4e30-b410-1c007e262560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
cee049ea-a476-433c-971f-2466a6a3263bAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
71335-0922-0Clonidine hydrochloride
71335-0922-0Clonidine hydrochloride
71335-0922-1Clonidine hydrochloride
71335-0922-1Clonidine hydrochloride
71335-0922-2Clonidine hydrochloride
71335-0922-2Clonidine hydrochloride
71335-0922-3Clonidine hydrochloride
71335-0922-3Clonidine hydrochloride
71335-0922-4Clonidine hydrochloride
71335-0922-4Clonidine hydrochloride
71335-0922-5Clonidine hydrochloride
71335-0922-5Clonidine hydrochloride
71335-0922-6Clonidine hydrochloride
71335-0922-6Clonidine hydrochloride
71335-0922-7Clonidine hydrochloride
71335-0922-7Clonidine hydrochloride
71335-0922-8Clonidine hydrochloride
71335-0922-8Clonidine hydrochloride
71335-0922-9Clonidine hydrochloride
71335-0922-9Clonidine hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0922-0Clonidine hydrochloride24 in 1 BOTTLETABLET245
71335-0922-1Clonidine hydrochloride100 in 1 BOTTLETABLET1005
71335-0922-2Clonidine hydrochloride30 in 1 BOTTLETABLET305
71335-0922-3Clonidine hydrochloride20 in 1 BOTTLETABLET205
71335-0922-4Clonidine hydrochloride60 in 1 BOTTLETABLET605
71335-0922-5Clonidine hydrochloride120 in 1 BOTTLETABLET1205
71335-0922-6Clonidine hydrochloride90 in 1 BOTTLETABLET905
71335-0922-7Clonidine hydrochloride10 in 1 BOTTLETABLET105
71335-0922-8Clonidine hydrochloride45 in 1 BOTTLETABLET455
71335-0922-9Clonidine hydrochloride14 in 1 BOTTLETABLET145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0922CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20220202_cee049ea-a476-433c-971f-2466a6a3263b.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
ndc (package): 71335-0922-6
ndc (product): 71335-0922
ndc11 (package): 71335092206
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNcee049ea-a476-433c-971f-2466a6a3263b5
884173clonidine hydrochloride 0.1 MG Oral TabletSCDcee049ea-a476-433c-971f-2466a6a3263b5
884173clonidine HCl 100 MCG Oral TabletSYcee049ea-a476-433c-971f-2466a6a3263b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0922-67133509220690 TABLET in 1 BOTTLE (71335-0922-6) 90 tablet2018-08-030000-00-00NoNoCurrent