Home NDC 42571-315 Clobazam
Product NDC 42571-315
11-digit product format 425710315
Labeler code 42571
Product ID 42571-315_50d350cb-6640-b3c2-e063-6394a90a397b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobazam
Dosage form TABLET
Route ORAL
Labeler Micro Labs Limited
Application ANDA211711
Marketing category ANDA
Marketing start 2019-04-02
Substance CLOBAZAM
Active strength 10 mg/1
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 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211711-001 CLOBAZAM CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 A211711-002 CLOBAZAM CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211711-001 CLOBAZAM 10MG TABLET / ORAL AB 2019-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211711-002 CLOBAZAM 20MG TABLET / ORAL AB 2019-01-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clobazam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBAZAM 10 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199450 Internal RxNorm lookup 246172 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-315 CLOBAZAM (CLOBAZAM) TABLET [MICRO LABS LIMITED] 8 Current NDC, Legacy NDC, 8 package rows 20240321_721dde68-db83-4dad-8649-8046cb455372.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 42571-315-01 42571031501 100 TABLET in 1 BOTTLE (42571-315-01) 100 tablet 2019-04-02 0000-00-00 No No Current 42571-315-05 42571031505 500 TABLET in 1 BOTTLE (42571-315-05) 500 tablet 2019-04-02 0000-00-00 No No Current 42571-315-11 42571031511 100 BLISTER PACK in 1 CARTON (42571-315-11) / 10 TABLET in 1 BLISTER PACK (42571-315-32) 100 blister pack 2019-04-02 0000-00-00 No No Current 42571-315-20 42571031520 10 in 1 BLISTER PACK Historical 42571-315-30 42571031530 30 TABLET in 1 BOTTLE (42571-315-30) 30 tablet 2019-04-02 0000-00-00 No No Current 42571-315-32 42571031532 10 in 1 BLISTER PACK Historical 42571-315-90 42571031590 90 TABLET in 1 BOTTLE (42571-315-90) 90 tablet 2019-04-02 0000-00-00 No No Current 42571-315-91 42571031591 100 BLISTER PACK in 1 CARTON (42571-315-91) / 10 TABLET in 1 BLISTER PACK (42571-315-20) 100 blister pack 2019-04-02 0000-00-00 No No Current