Home NDC 21695-567 Catapres
Product NDC 21695-567
11-digit product format 216950567
Labeler code 21695
Product ID 21695-567_f4ac82b0-d0fb-4720-a277-5b2b8013cb3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler Rebel Distributors Corp
Application NDA018891
Marketing category NDA
Marketing start 1985-10-01
Marketing end 0000-00-00
Substance CLONIDINE
Active strength 0 mg/24h
Pharmacologic classes Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 21695-567-04 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 21695-567-04 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 21695-567-04 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 21695-567-04 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 21695-567-04 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 21695-567-04 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 21695-567-04 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 21695-567-04 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 21695-567-04 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 21695-567-04 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 21695-567-04 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 21695-567-04 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 21695-567-04 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 21695-567-04 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 21695-567-04 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 21695-567-04 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 21695-567-04 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 21695-567-04 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 21695-567-04 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 21695-567-04 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 21695-567-04 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 21695-567-04 110d247fa046…a55b01930146…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018891-001 CATAPRES-TTS-1 CLONIDINE 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 N018891-002 CATAPRES-TTS-2 CLONIDINE 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 N018891-003 CATAPRES-TTS-3 CLONIDINE 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-567-04 Catapres 4 in 1 CARTON PATCH, EXTENDED RELEASE 4 1 21695-567-04 Catapres 1 in 1 POUCH PATCH, EXTENDED RELEASE 1 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-567 CATAPRES (CLONIDINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 2 package rows 20110622_f4ac82b0-d0fb-4720-a277-5b2b8013cb3f.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clonidine Transdermal System USP, 0.1 mg/day CLONIDINE TRANSDERMAL SYSTEM TruPharma, LLC 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b 2026-03-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 018891 application number: NDA018891 Catapres-TTS-1 CLONIDINE TRANSDERMAL SYSTEM Technomed Inc. 39e1d35e-533c-4647-8649-8168a6e92dfa 2026-01-06 Warnings, Adverse reactions Exact identifier application applno (NDA): 018891 application number: NDA018891 Clonidine Transdermal System USP, 0.1 mg/day CLONIDINE TRANSDERMAL SYSTEM TruPharma, LLC 05d520bf-3ab7-4337-9f38-4418e5e7e1e9 2025-04-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 018891 application number: NDA018891 Catapres-TTS-1 CLONIDINE TRANSDERMAL SYSTEM Technomed Inc. d4a55825-7041-42f4-b3b2-dd7a25dbe793 2024-10-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 018891 application number: NDA018891
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-567-04 21695056704 4 in 1 CARTON Historical