Home NDC 67386-315-01 Onfi
Product NDC 67386-315
Requested package NDC 67386-315-01
11-digit product format 673860315
Labeler code 67386
Product ID 67386-315_f39e2e84-9fe0-4c3d-ad04-b3188e1e92fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobazam
Dosage form TABLET
Route ORAL
Labeler Lundbeck Pharmaceuticals LLC
Application NDA202067
Marketing category NDA
Marketing start 2013-12-10
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202067-001 ONFI CLOBAZAM 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 N202067-002 ONFI CLOBAZAM 10MG TABLET / ORAL AB RLD 2011-10-21 N202067-003 ONFI CLOBAZAM 20MG TABLET / ORAL AB RLD, RS 2011-10-21
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 4 · 132 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 2026-10-15 13:18:30 2026-09 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202067-002 ONFI 10MG TABLET / ORAL AB RLD 2011-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202067-003 ONFI 20MG TABLET / ORAL AB RLD, RS 2011-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202067-001 ONFI 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-10-21 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Onfi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBAZAM 20 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67386-315-01 Onfi 100 in 1 BOTTLE TABLET 100 42 67386-315-01 Onfi 1 in 1 CARTON TABLET 1 42
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67386-315 ONFI (CLOBAZAM) TABLET ONFI (CLOBAZAM) SUSPENSION [LUNDBECK PHARMACEUTICALS LLC] 41 Current NDC, Legacy NDC, 2 package rows 20241222_de03bd69-2dca-459c-93b4-541fd3e9571c.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 67386-315-01 67386031501 1 BOTTLE in 1 CARTON (67386-315-01) / 100 TABLET in 1 BOTTLE 1 bottle 2013-12-10 0000-00-00 No No Current