Oxazepam

Product NDC
62584-814
11-digit product format
625840814
Labeler code
62584
Product ID
62584-814_26e63053-7a43-e278-e063-6394a90a23b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxazepam
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA072253
Marketing category
ANDA
Marketing start
2007-12-17
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
A072253-001OXAZEPAMOXAZEPAM30MGCAPSULE / ORALABRS1988-04-14
A072253-002OXAZEPAMOXAZEPAM10MGCAPSULE / ORALAB1988-04-14
A072253-003OXAZEPAMOXAZEPAM15MGCAPSULE / ORALAB1988-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072253-001AB
A072253-002AB
A072253-003AB

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 UTC2026-02A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072253-002OXAZEPAM10MGCAPSULE / ORALAB1988-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072253-003OXAZEPAM15MGCAPSULE / ORALAB1988-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072253-001OXAZEPAM30MGCAPSULE / ORALABRS1988-04-148072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072253-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072253-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072253-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072253-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072253-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072253-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072253-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072253-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072253-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072253-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072253-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072253-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072253-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072253-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072253-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072253-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072253-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072253-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072253-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072253-001AB18072bd15b7f6…

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
03440821-831c-4085-98f9-faa88e98c503Available 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
62584-814-01Oxazepam100 in 1 CARTONCAPSULE, GELATIN COATED10012
62584-814-11Oxazepam1 in 1 BLISTER PACKCAPSULE, GELATIN COATED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62584-814-01EA - Each62584-8143e7e60ea-c982-42b5-a068-e3f82baab1ed12012-07-24
62584-814-11EA - Each62584-814d941d4fe-8313-400b-9f6b-f3a7255bd7e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXAZEPAMACTIVE INGREDIENT6GOW6DWN2AOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
OXAZEPAMACTIVE MOIETY6GOW6DWN2AOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
GELATININACTIVE INGREDIENT2G86QN327LOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62584-814OXAZEPAM CAPSULE, GELATIN COATED [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 2 package rows20241116_03440821-831c-4085-98f9-faa88e98c503.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
OxazepamOXAZEPAMAmerican Health Packaging03440821-831c-4085-98f9-faa88e98c5032024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072253
application number: ANDA072253
ndc (product): 62584-814
OxazepamOXAZEPAMActavis Pharma, Inc.a0d5a4c1-ec79-42e6-8e8f-ae4d144edb432023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072253
application number: ANDA072253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198057oxazepam 10 MG Oral CapsulePSN03440821-831c-4085-98f9-faa88e98c50312
312134oxazepam 15 MG Oral CapsulePSN03440821-831c-4085-98f9-faa88e98c50312
198059oxazepam 30 MG Oral CapsulePSN03440821-831c-4085-98f9-faa88e98c50312
198057oxazepam 10 MG Oral CapsuleSCD03440821-831c-4085-98f9-faa88e98c50312
312134oxazepam 15 MG Oral CapsuleSCD03440821-831c-4085-98f9-faa88e98c50312
198059oxazepam 30 MG Oral CapsuleSCD03440821-831c-4085-98f9-faa88e98c50312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62584-814-0162584081401100 BLISTER PACK in 1 CARTON (62584-814-01) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (62584-814-11) 100 blister pack2007-12-170000-00-00NoNoCurrent
62584-814-11625840814111 in 1 BLISTER PACKHistorical