Home NDC 71610-639 Oxazepam
Product NDC 71610-639
11-digit product format 716100639
Labeler code 71610
Product ID 71610-639_7aebd188-6319-41ca-950d-352ced2eeb19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxazepam
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA071026
Marketing category ANDA
Marketing start 2021-06-01
Substance OXAZEPAM
Active strength 15 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071026-001 OXAZEPAM OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 A071026-002 OXAZEPAM OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 A071026-003 OXAZEPAM OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10
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 4 · 123 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 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071026-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1987-08-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071026-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1987-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071026-001 OXAZEPAM 30MG CAPSULE / ORAL AB 1987-08-10 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXAZEPAM 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6GOW6DWN2A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312134 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-639-30 Oxazepam 30 in 1 BOTTLE CAPSULE 30 1 71610-639-53 Oxazepam 60 in 1 BOTTLE CAPSULE 60 1 71610-639-60 Oxazepam 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-639 OXAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 3 package rows 20220311_f1e50d01-f529-4894-97d4-0af680a8b461.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 · 2 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 71610-639-30 71610063930 30 CAPSULE in 1 BOTTLE (71610-639-30) 30 capsule 2022-03-09 0000-00-00 No No Current 71610-639-53 71610063953 60 CAPSULE in 1 BOTTLE (71610-639-53) 60 capsule 2022-03-09 0000-00-00 No No Current 71610-639-60 71610063960 90 CAPSULE in 1 BOTTLE (71610-639-60) 90 capsule 2022-03-09 0000-00-00 No No Current