Home NDC 51672-4227 Clobazam
Product NDC 51672-4227
11-digit product format 516724227
Labeler code 51672
Product ID 51672-4227_1fd3064f-ed73-9de1-e063-6294a90a0d97
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 2021-06-30
Substance CLOBAZAM
Active strength 2.5 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 2026-12-31
Current FDA listing Yes 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# Additional Listing Data#
Finished product Yes
Brand name base Clobazam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBAZAM 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2MRO291B4U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1366192 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-4227-8 Clobazam 120 mL in 1 BOTTLE SUSPENSION 120 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4227 CLOBAZAM SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240817_fd1e63bf-496c-427c-83b7-6acabc00a5e5.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 · 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 ndc (product): 51672-4227
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 51672-4227-8 51672422708 120 mL in 1 BOTTLE (51672-4227-8) 120 ml 2021-06-30 0000-00-00 No No Current