Oxazepam

Product NDC
52817-292
11-digit product format
528170292
Labeler code
52817
Product ID
52817-292_2a9ebd02-ff4a-2aa2-e063-6394a90a6fde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA071026
Marketing category
ANDA
Marketing start
2021-06-01
Substance
OXAZEPAM
Active strength
30 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071026-001OXAZEPAMOXAZEPAM30MGCAPSULE / ORALAB1987-08-10
A071026-002OXAZEPAMOXAZEPAM10MGCAPSULE / ORALAB1987-08-10
A071026-003OXAZEPAMOXAZEPAM15MGCAPSULE / ORALAB1987-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A071026-001AB
A071026-002AB
A071026-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071026-002OXAZEPAM10MGCAPSULE / ORALAB1987-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071026-003OXAZEPAM15MGCAPSULE / ORALAB1987-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071026-001OXAZEPAM30MGCAPSULE / ORALAB1987-08-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071026-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071026-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071026-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071026-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071026-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071026-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071026-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071026-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071026-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071026-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071026-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071026-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071026-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071026-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071026-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071026-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071026-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071026-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071026-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071026-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071026-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071026-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071026-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071026-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071026-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071026-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071026-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071026-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071026-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071026-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071026-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071026-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071026-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071026-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071026-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071026-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071026-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071026-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071026-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071026-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXAZEPAM30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6GOW6DWN2AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198057Internal RxNorm lookup
198059Internal RxNorm lookup
312134Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bda8bc70-3328-46f2-89d5-7ef7a061b418Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0bf93631-d4c9-1bc6-b689-709626127556Product name220251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-292-10Oxazepam100 in 1 BOTTLECAPSULE1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-292OXAZEPAM CAPSULE [TRUPHARMA, LLC]9Current NDC, Legacy NDC, 1 package rows20250102_bda8bc70-3328-46f2-89d5-7ef7a061b418.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxazepamOXAZEPAMAphena Pharma Solutions - Tennessee, LLCf1e50d01-f529-4894-97d4-0af680a8b4612022-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071026
application number: ANDA071026
OxazepamOXAZEPAMTruPharma, LLCbda8bc70-3328-46f2-89d5-7ef7a061b4182021-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071026
application number: ANDA071026
ndc (product): 52817-292

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198057oxazepam 10 MG Oral CapsulePSNbda8bc70-3328-46f2-89d5-7ef7a061b4189
312134oxazepam 15 MG Oral CapsulePSNbda8bc70-3328-46f2-89d5-7ef7a061b4189
198059oxazepam 30 MG Oral CapsulePSNbda8bc70-3328-46f2-89d5-7ef7a061b4189
198057oxazepam 10 MG Oral CapsuleSCDbda8bc70-3328-46f2-89d5-7ef7a061b4189
312134oxazepam 15 MG Oral CapsuleSCDbda8bc70-3328-46f2-89d5-7ef7a061b4189
198059oxazepam 30 MG Oral CapsuleSCDbda8bc70-3328-46f2-89d5-7ef7a061b4189

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-292-1052817029210100 CAPSULE in 1 BOTTLE (52817-292-10) 100 capsule2021-06-010000-00-00NoNoCurrent