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 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 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.
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 2026-08-01 22:54:32 2026-06 A208819-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2018-10-22 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A208819-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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