Catapres

Product NDC
0597-0006
11-digit product format
005970006
Labeler code
0597
Product ID
0597-0006_fca3ee1c-4468-dd19-264b-df5e54f31518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals Inc.
Application
NDA017407
Marketing category
NDA
Marketing start
1999-05-01
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
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0597-0006DDiscontinued by firm2026-08-03
excluded packagepackage0597-00060597-0006-01DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0006-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0006-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0006-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0006-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0597-0006-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0597-0006-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0597-0006-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0597-0006-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0597-0006-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0597-0006-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0597-0006-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0597-0006-01557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017407-001CATAPRESCLONIDINE HYDROCHLORIDE0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017407-002CATAPRESCLONIDINE HYDROCHLORIDE0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017407-003CATAPRESCLONIDINE HYDROCHLORIDE0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017407-002CATAPRES0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017407-003CATAPRES0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017407-001CATAPRES0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N017407-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017407-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017407-003AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017407-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017407-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017407-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017407-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017407-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017407-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017407-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017407-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017407-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017407-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017407-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017407-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017407-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N017407-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N017407-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017407-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N017407-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N017407-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017407-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N017407-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N017407-003AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0006-01EA - Each0597-00066579efd5-4a99-4099-ac80-b079979c224e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clonidine hydrochlorideACTIVE INGREDIENTW76I6XXF06CATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
clonidineACTIVE MOIETYMN3L5RMN02CATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
dibasic calcium phosphate dihydrateINACTIVE INGREDIENTO7TSZ97GEPCATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYCATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8CATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
gelatinINACTIVE INGREDIENT2G86QN327LCATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
glycerinINACTIVE INGREDIENTPDC6A3C0OXCATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
lactoseINACTIVE INGREDIENTJ2B2A4N98GCATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
magnesium stearateINACTIVE INGREDIENT70097M6I30CATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7
starch, cornINACTIVE INGREDIENTO8232NY3SJCATAPRES (CLONIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0006-0100597000601100 TABLET in 1 BOTTLE, PLASTIC (0597-0006-01) 100 tablet1999-05-010000-00-00NoNoCurrent