Home NDC 42806-572 Oxazepam
Product NDC 42806-572
11-digit product format 428060572
Labeler code 42806
Product ID 42806-572_bb6d9142-3647-4591-8f84-31b61b755634
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxazepam
Dosage form CAPSULE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA071756
Marketing category ANDA
Marketing start 1988-04-19
Substance OXAZEPAM
Active strength 10 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
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 43 .
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 A071756-001 OXAZEPAM OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 A071756-002 OXAZEPAM OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-19 A071756-003 OXAZEPAM OXAZEPAM 30MG CAPSULE / ORAL AB 1988-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 55 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 2026-09-14 22:38:34 2026-08 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071756-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071756-003 OXAZEPAM 30MG CAPSULE / ORAL AB 1988-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071756-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071756-003 OXAZEPAM 30MG CAPSULE / ORAL AB 1988-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071756-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071756-003 OXAZEPAM 30MG CAPSULE / ORAL AB 1988-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071756-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071756-003 OXAZEPAM 30MG CAPSULE / ORAL AB 1988-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071756-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071756-003 OXAZEPAM 30MG CAPSULE / ORAL AB 1988-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071756-001 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-19 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 55 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 Oxazepam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXAZEPAM 10 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42806-572-01 42806057201 100 CAPSULE in 1 BOTTLE (42806-572-01) 100 capsule 1988-04-19 No No Current