Catapres-TTS

Product NDC
0597-0032
11-digit product format
005970032
Labeler code
0597
Product ID
0597-0032_cf4b3b2a-f712-4ff5-87f2-91eb4b4bc39f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Boehringer Ingelheim Pharmaceuticals Inc.
Application
NDA018891
Marketing category
NDA
Marketing start
1985-10-01
Marketing end
2023-12-31
Substance
CLONIDINE
Active strength
0 mg/d
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0597-0032DDiscontinued by firm2026-08-17
excluded packagepackage0597-00320597-0032-34DDiscontinued by firm2026-08-17

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 packagepackage0597-0032-34d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0032-34f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0032-342ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0032-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0597-0032-34cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0597-0032-34cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0597-0032-34302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0597-0032-34ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0597-0032-340efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0597-0032-34ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0597-0032-34367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0597-0032-34557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N018891-001CATAPRES-TTS-1CLONIDINE0.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10
N018891-002CATAPRES-TTS-2CLONIDINE0.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10
N018891-003CATAPRES-TTS-3CLONIDINE0.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018891-001AB
N018891-002AB
N018891-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10caaa826d4ba7…
2026-08-18 06:07:402026-07N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10caaa826d4ba7…
2026-08-18 06:07:402026-07N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018891-002CATAPRES-TTS-20.2MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018891-003CATAPRES-TTS-30.3MG/24HRSYSTEM / TRANSDERMALABRLD, RS1984-10-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018891-001CATAPRES-TTS-10.1MG/24HRSYSTEM / TRANSDERMALABRLD1984-10-101e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018891-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018891-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018891-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018891-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018891-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018891-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018891-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018891-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018891-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018891-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018891-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018891-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018891-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018891-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018891-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018891-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018891-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018891-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018891-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018891-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018891-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018891-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018891-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018891-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018891-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018891-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018891-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018891-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018891-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018891-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018891-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018891-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018891-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018891-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018891-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018891-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018891-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018891-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018891-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018891-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0032-34EA - Each0597-0032cea1ac67-52b3-495c-91cf-b635ae28c9c012012-07-24

DailyMed Socrata Ingredients#

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine Transdermal System USP, 0.1 mg/dayCLONIDINE TRANSDERMAL SYSTEMTruPharma, LLC0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b2026-03-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018891
application number: NDA018891
Catapres-TTS-1CLONIDINE TRANSDERMAL SYSTEMTechnomed Inc.39e1d35e-533c-4647-8649-8168a6e92dfa2026-01-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 018891
application number: NDA018891
Clonidine Transdermal System USP, 0.1 mg/dayCLONIDINE TRANSDERMAL SYSTEMTruPharma, LLC05d520bf-3ab7-4337-9f38-4418e5e7e1e92025-04-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 018891
application number: NDA018891
Catapres-TTS-1CLONIDINE TRANSDERMAL SYSTEMTechnomed Inc.d4a55825-7041-42f4-b3b2-dd7a25dbe7932024-10-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 018891
application number: NDA018891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0032-34005970032344 POUCH in 1 CARTON (0597-0032-34) > 1 PATCH in 1 POUCH > 1 d in 1 PATCH4 pouch1985-10-010000-00-00NoNoCurrent