Home NDC 69539-154 CLOBAZAM
Product NDC 69539-154
11-digit product format 695390154
Labeler code 69539
Product ID 69539-154_f0859b0e-5ed1-4d6c-a3ae-7b6d8a2adb02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOBAZAM
Dosage form TABLET
Route ORAL
Labeler MSN LABORATORIES PRIVATE LIMITED
Application ANDA213404
Marketing category ANDA
Marketing start 2021-05-12
Marketing end 0000-00-00
Substance CLOBAZAM
Active strength 20 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 2022-12-31
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 69539-154 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69539-154 69539-154-99 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69539-154 69539-154-91 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A213404-001 CLOBAZAM CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 A213404-002 CLOBAZAM CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11
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 2 · 66 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 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213404-001 CLOBAZAM 10MG TABLET / ORAL 2021-05-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213404-002 CLOBAZAM 20MG TABLET / ORAL 2021-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213404-001 CLOBAZAM 10MG TABLET / ORAL 2021-05-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213404-002 CLOBAZAM 20MG TABLET / ORAL 2021-05-11 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213404-001 CLOBAZAM 10MG TABLET / ORAL AB 2021-05-11 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213404-002 CLOBAZAM 20MG TABLET / ORAL AB 2021-05-11 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69539-154 CLOBAZAM TABLET [MSN LABORATORIES PRIVATE LIMITED] 2 Legacy NDC 20210514_10b6dc5c-19e8-4192-9de4-7ffa9a585344.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 Novadoz Pharmaceuticals LLC cf5bb37f-5386-47d3-8cec-d48253d359f6 2024-07-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213404 application number: ANDA213404
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69539-154-91 69539015491 1 BOTTLE in 1 CARTON (69539-154-91) > 100 TABLET in 1 BOTTLE 1 bottle 2021-05-12 0000-00-00 No No Current 69539-154-99 69539015499 1 BOTTLE in 1 CARTON (69539-154-99) > 1000 TABLET in 1 BOTTLE 1 bottle 2021-05-12 0000-00-00 No No Current