Home NDC 0228-2067-00 Oxazepam
Product NDC 0228-2067
Requested package NDC 0228-2067-00
11-digit product format 002282067
Labeler code 0228
Product ID 0228-2067_f191a7db-b292-4119-b144-b25c0555b050
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxazepam
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA072253
Marketing category ANDA
Marketing start 2007-01-02
Substance OXAZEPAM
Active strength 10 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 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 · 14 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…
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.
Additional Listing Data#
Finished product Yes
Brand name base Oxazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXAZEPAM 10 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198057 Internal RxNorm lookup 198059 Internal RxNorm lookup 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 0228-2067-10 Oxazepam 100 in 1 BOTTLE CAPSULE, GELATIN COATED 100 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXAZEPAM ACTIVE INGREDIENT 6GOW6DWN2A OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 OXAZEPAM ACTIVE MOIETY 6GOW6DWN2A OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] 4 OXAZEPAM ACTIVE INGREDIENT 6GOW6DWN2A OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 OXAZEPAM ACTIVE MOIETY 6GOW6DWN2A OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS ELIZABETH LLC] 3 OXAZEPAM ACTIVE INGREDIENT 6GOW6DWN2A OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 OXAZEPAM ACTIVE MOIETY 6GOW6DWN2A OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-2067 OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] 19 Current NDC, Legacy NDC, 1 package rows 20240123_a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43.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 Marketing start Status 0228-2067-00 00228206700 12020 CAPSULE, GELATIN COATED in 1 BOX (0228-2067-00) 29-SEP-23 Current