Catapres-TTS-3

Product NDC
82089-103
11-digit product format
820890103
Labeler code
82089
Product ID
82089-103_e826dfa2-e206-4274-8354-c47f17a04f5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine transdermal system
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Technomed Inc.
Application
NDA018891
Marketing category
NDA
Marketing start
2022-03-01
Marketing end
2026-10-30
Substance
CLONIDINE
Active strength
.3 mg/d
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Catapres-TTS-3

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE.3 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MN3L5RMN02Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998671Internal RxNorm lookup
998673Internal RxNorm lookup
998675Internal RxNorm lookup
998677Internal RxNorm lookup
998679Internal RxNorm lookup
998681Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4a55825-7041-42f4-b3b2-dd7a25dbe793Available 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
82089-103-34Catapres-TTS-34 in 1 CARTONPATCH44
82089-103-34Catapres-TTS-31 in 1 POUCHPATCH14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82089-103-34EA - Each82089-103df126c03-834f-4914-86ce-fc1114cb6eff12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82089-103CATAPRES-TTS-1 (CLONIDINE TRANSDERMAL SYSTEM) PATCH CATAPRES-TTS-2 (CLONIDINE TRANSDERMAL SYSTEM) PATCH CATAPRES-TTS-3 (CLONIDINE TRANSDERMAL SYSTEM) PATCH [TECHNOMED INC.]4Current NDC, Legacy NDC, 2 package rows20241018_d4a55825-7041-42f4-b3b2-dd7a25dbe793.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 · 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
ndc (product): 82089-103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998673Catapres-TTS-1, 0.1 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677Catapres-TTS-2, 0.2 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681Catapres-TTS-3, 0.3 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998671cloNIDine HCl 0.1 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998675cloNIDine HCl 0.2 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998679cloNIDine HCl 0.3 MG/Day Weekly Transdermal SystemPSNd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673168 HR clonidine 0.00417 MG/HR Transdermal System [Catapres]SBDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677168 HR clonidine 0.00833 MG/HR Transdermal System [Catapres]SBDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681168 HR clonidine 0.0125 MG/HR Transdermal System [Catapres]SBDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998671168 HR clonidine 0.00417 MG/HR Transdermal SystemSCDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998675168 HR clonidine 0.00833 MG/HR Transdermal SystemSCDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998679168 HR clonidine 0.0125 MG/HR Transdermal SystemSCDd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673168 HR Catapres 0.00417 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677168 HR Catapres 0.00833 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681168 HR Catapres 0.0125 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673168 HR Catapres-TTS-1 0.00417 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677168 HR Catapres-TTS-2 0.00833 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681168 HR Catapres-TTS-3 0.0125 MG/HR Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673Catapres-TTS-1 0.1 MG/Day Weekly Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998673Catapres-TTS-1, 0.1 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677Catapres-TTS-2, 0.2 MG/Day 7 Day Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998677Catapres-TTS-2, 0.2 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681Catapres-TTS-3, 0.3 MG/Day 7 Day Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998681Catapres-TTS-3, 0.3 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998671clonidine HCl 0.1 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998675clonidine HCl 0.2 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998679clonidine HCl 0.3 MG/Day Weekly Transdermal SystemSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998671clonidine hydrochloride 0.1 MG/Day Weekly Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998675clonidine hydrochloride 0.2 MG/Day Weekly Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934
998679clonidine hydrochloride 0.3 MG/Day Weekly Transdermal PatchSYd4a55825-7041-42f4-b3b2-dd7a25dbe7934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82089-103-34820890103344 POUCH in 1 CARTON (82089-103-34) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH4 pouch2022-03-012026-10-30NoNoCurrent