Home NDC 46708-307 clonidine hydrochloride
Product NDC 46708-307
11-digit product format 467080307
Labeler code 46708
Product ID 46708-307_5c1950f4-ba20-4347-8ca0-f50a2d66c039
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonidine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA091368
Marketing category ANDA
Marketing start 2016-05-03
Substance CLONIDINE HYDROCHLORIDE
Active strength .2 mg/1
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091368-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 A091368-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 A091368-003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06
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 · 129 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 2026-09-14 22:38:34 2026-08 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base clonidine hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE HYDROCHLORIDE .2 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-307-10 clonidine hydrochloride 100 in 1 CARTON TABLET 100 4 46708-307-30 clonidine hydrochloride 30 in 1 BOTTLE TABLET 30 4 46708-307-31 clonidine hydrochloride 100 in 1 BOTTLE TABLET 100 4 46708-307-71 clonidine hydrochloride 500 in 1 BOTTLE TABLET 500 4 46708-307-91 clonidine hydrochloride 1000 in 1 BOTTLE TABLET 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-307 CLONIDINE HYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 4 Current NDC, Legacy NDC, 5 package rows 20230129_88a8db46-0fc9-48cd-b7cc-ac9c9cdea100.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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46708-307-10 46708030710 100 TABLET in 1 CARTON (46708-307-10) 100 tablet 2016-05-03 0000-00-00 No No Current 46708-307-30 46708030730 30 TABLET in 1 BOTTLE (46708-307-30) 30 tablet 2016-05-03 0000-00-00 No No Current 46708-307-31 46708030731 100 TABLET in 1 BOTTLE (46708-307-31) 100 tablet 2016-05-03 0000-00-00 No No Current 46708-307-71 46708030771 500 TABLET in 1 BOTTLE (46708-307-71) 500 tablet 2016-05-03 0000-00-00 No No Current 46708-307-91 46708030791 1000 TABLET in 1 BOTTLE (46708-307-91) 1000 tablet 2016-05-03 0000-00-00 No No Current