Clonidine hydrochloride

Product NDC
71335-1624
Requested package NDC
71335-1624-4
11-digit product format
713351624
Labeler code
71335
Product ID
71335-1624_33d61efe-5a9c-485f-a687-1a879fa91cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070923
Marketing category
ANDA
Marketing start
2017-06-01
Marketing end
0000-00-00
Substance
CLONIDINE HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-162471335-1624-4DDiscontinued by firm2026-08-03

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 · 27 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070923-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-04
A070923-002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-04
A070923-003CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-04
A070923-004CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.05MGTABLET / ORALRS2026-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A070923-001AB
A070923-002AB
A070923-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070923-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB1987-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070923-003CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1987-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070923-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1987-09-048072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070923-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070923-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070923-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070923-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070923-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070923-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070923-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070923-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070923-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070923-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070923-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070923-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070923-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070923-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070923-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070923-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070923-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070923-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070923-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070923-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070923-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070923-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070923-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070923-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070923-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070923-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070923-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070923-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070923-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070923-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070923-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070923-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070923-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070923-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070923-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070923-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070923-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070923-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070923-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070923-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.3 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
884189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f65d90dc-11b4-4d63-b4a9-30603bc332eaAvailable 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1624-1Clonidine hydrochloride60 in 1 BOTTLETABLET60100
71335-1624-2Clonidine hydrochloride30 in 1 BOTTLETABLET30100
71335-1624-3Clonidine hydrochloride90 in 1 BOTTLETABLET90100
71335-1624-4Clonidine hydrochloride120 in 1 BOTTLETABLET120100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1624CLONIDINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Legacy NDC, 4 package rows20220211_f65d90dc-11b4-4d63-b4a9-30603bc332ea.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackf65d90dc-11b4-4d63-b4a9-30603bc332ea2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070923
application number: ANDA070923
ndc (package): 71335-1624-4
ndc (product): 71335-1624
ndc11 (package): 71335162404
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEUnit Dose Solutions, Inc.544ea5bf-6713-f034-e063-6394a90a781b2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070923
application number: ANDA070923
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDETruPharma, LLCc83e4e4f-bd0e-449d-958a-dc0d570a01ba2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070923
application number: ANDA070923
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDENorthwind Health Company, LLCf30324be-47b6-7f54-e053-2995a90a3ad42026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070923
application number: ANDA070923
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAsclemed USA, Inc.e8c7aa08-1450-de68-e053-2995a90ad0b62022-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070923
application number: ANDA070923
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC00d1562d-b4eb-4d89-95de-0aacee7a82a52020-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070923
application number: ANDA070923

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSNf65d90dc-11b4-4d63-b4a9-30603bc332ea100
884189clonidine hydrochloride 0.3 MG Oral TabletSCDf65d90dc-11b4-4d63-b4a9-30603bc332ea100
884189clonidine HCl 300 MCG Oral TabletSYf65d90dc-11b4-4d63-b4a9-30603bc332ea100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1624-471335162404120 TABLET in 1 BOTTLE (71335-1624-4) 120 tablet2022-02-100000-00-00NoNoCurrent