Home NDC 51672-4210-8 Clobazam
Product NDC 51672-4210
Requested package NDC 51672-4210-8
11-digit product format 516724210
Labeler code 51672
Product ID 51672-4210_42e2146c-a750-4c71-b6be-b1101c662454
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobazam
Dosage form SUSPENSION
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA210978
Marketing category ANDA
Marketing start 2019-04-16
Marketing end 0000-00-00
Substance CLOBAZAM
Active strength 3 mg/mL
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2020-12-31
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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210978-001 CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210978-001 AB
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clobazam CLOBAZAM Sun Pharmaceutical Industries, Inc. fd1e63bf-496c-427c-83b7-6acabc00a5e5 2026-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210978 application number: ANDA210978
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4210-8 51672421008 1 BOTTLE in 1 CARTON (51672-4210-8) > 120 mL in 1 BOTTLE 1 bottle 2019-04-16 0000-00-00 No No Current