Home NDC 69452-116 Clobazam
Product NDC 69452-116
11-digit product format 694520116
Labeler code 69452
Product ID 69452-116_27d7f38a-1122-d6bb-e063-6394a90a5cd8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobazam
Dosage form SUSPENSION
Route ORAL
Labeler Bionpharma Inc.
Application ANDA208819
Marketing category ANDA
Marketing start 2017-10-20
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 42 .
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 A208819-001 CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208819-001 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 · 42 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 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clobazam
Listing expiration 2026-12-31 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 69452-116-45 Clobazam 120 mL in 1 BOTTLE SUSPENSION 120 10 69452-116-45 Clobazam 1 in 1 CARTON SUSPENSION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-116 CLOBAZAM SUSPENSION [BIONPHARMA INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241207_4b92ac57-25aa-4c00-b062-dee3944b271b.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.
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 69452-116-45 69452011645 1 BOTTLE in 1 CARTON (69452-116-45) / 120 mL in 1 BOTTLE 1 bottle 2017-10-20 0000-00-00 No No Current