Home NDC 43353-074 Oxazepam
Product NDC 43353-074
11-digit product format 433530074
Labeler code 43353
Product ID 43353-074_c1cede8c-12ef-4678-be73-35f8b16f2fe3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxazepam
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, Inc.
Application ANDA072253
Marketing category ANDA
Marketing start 2007-01-02
Marketing end 0000-00-00
Substance OXAZEPAM
Active strength 30 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-074-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-074-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43353-074-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43353-074-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43353-074-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43353-074-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43353-074-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43353-074-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43353-074-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43353-074-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43353-074-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43353-074-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-074-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-074-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-074-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43353-074-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43353-074-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43353-074-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43353-074-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 43353-074-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 43353-074-30 9bebd1f3094a…5416666fcb17…
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 A072253-001 OXAZEPAM OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 A072253-002 OXAZEPAM OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 A072253-003 OXAZEPAM OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14
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 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072253-002 OXAZEPAM 10MG CAPSULE / ORAL AB 1988-04-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072253-003 OXAZEPAM 15MG CAPSULE / ORAL AB 1988-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072253-001 OXAZEPAM 30MG CAPSULE / ORAL AB RS 1988-04-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-074-30 Oxazepam 30 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXAZEPAM ACTIVE INGREDIENT 6GOW6DWN2A OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 OXAZEPAM ACTIVE MOIETY 6GOW6DWN2A OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-074 OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 Legacy NDC, 1 package rows 20120815_8b11788c-2386-4c4a-a9b0-de2bdccbadaa.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 Status 43353-074-30 43353007430 30 in 1 BOTTLE, PLASTIC Historical