Home NDC 0527-5301-64 Clobazam
Product NDC 0527-5301
Requested package NDC 0527-5301-64
11-digit product format 005275301
Labeler code 0527
Product ID 0527-5301_0c6e540f-d675-4932-855c-b17a4a12197e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobazam
Dosage form SUSPENSION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA213110
Marketing category ANDA
Marketing start 2020-04-24
Marketing end 2023-06-30
Substance CLOBAZAM
Active strength 3 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 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A213110-001 CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213110-001 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 2026-02-19 14:30 UTC 2026-02 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213110-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2020-04-24 a50c72e98297…
Observed Orange Book normalized TE history# 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 Chartwell RX, LLC 17c3b9db-9e25-4a17-ac45-bcd17ea0360c 2024-05-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213110 application number: ANDA213110
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0527-5301-64 00527530164 1 BOTTLE in 1 CARTON (0527-5301-64) > 120 mL in 1 BOTTLE 1 bottle 2020-04-24 2023-06-30 No No Current