OXAZEPAM

Product NDC: 69315-913
11-digit product format: 693150913
Labeler code: 69315
Product ID: 69315-913_708e4237-a898-4d23-90b1-253c18301884
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXAZEPAM
Dosage form: CAPSULE
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA218261
Marketing category: ANDA
Marketing start: 2025-07-09
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218261-001	OXAZEPAM	OXAZEPAM	10MG	CAPSULE / ORAL	AB	2025-03-03
A218261-002	OXAZEPAM	OXAZEPAM	15MG	CAPSULE / ORAL	AB	2025-03-03
A218261-003	OXAZEPAM	OXAZEPAM	30MG	CAPSULE / ORAL	AB	2025-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218261-001	AB
A218261-002	AB
A218261-003	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218261-001	OXAZEPAM	10MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218261-002	OXAZEPAM	15MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218261-003	OXAZEPAM	30MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218261-001	OXAZEPAM	10MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218261-002	OXAZEPAM	15MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218261-003	OXAZEPAM	30MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218261-001	OXAZEPAM	10MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218261-002	OXAZEPAM	15MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218261-003	OXAZEPAM	30MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218261-001	OXAZEPAM	10MG	CAPSULE / ORAL	AB	2025-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218261-002	OXAZEPAM	15MG	CAPSULE / ORAL	AB	2025-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218261-003	OXAZEPAM	30MG	CAPSULE / ORAL	AB	2025-03-03	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218261-001	OXAZEPAM	10MG	CAPSULE / ORAL	AB	2025-03-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218261-002	OXAZEPAM	15MG	CAPSULE / ORAL	AB	2025-03-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218261-003	OXAZEPAM	30MG	CAPSULE / ORAL	AB	2025-03-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218261-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218261-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218261-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218261-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218261-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218261-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218261-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218261-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218261-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218261-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218261-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218261-003	AB	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218261-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218261-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218261-003	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXAZEPAM	30 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
67f821fa-5663-4d69-82c9-5ee13a09f324	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0bf93631-d4c9-1bc6-b689-709626127556	Product name	2	20251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69315-913-01	OXAZEPAM	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-913-01	EA - Each	69315-913	50f3cd02-4618-4368-9d70-86d41d1bb31e	1	2025-08-11

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXAZEPAM	OXAZEPAM	Leading Pharma, LLC	67f821fa-5663-4d69-82c9-5ee13a09f324	2025-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218261 application number: ANDA218261 ndc (product): 69315-913

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6GOW6DWN2A	OXAZEPAM	604-75-1	OXAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198057	oxazepam 10 MG Oral Capsule	PSN	67f821fa-5663-4d69-82c9-5ee13a09f324	3
312134	oxazepam 15 MG Oral Capsule	PSN	67f821fa-5663-4d69-82c9-5ee13a09f324	3
198059	oxazepam 30 MG Oral Capsule	PSN	67f821fa-5663-4d69-82c9-5ee13a09f324	3
198057	oxazepam 10 MG Oral Capsule	SCD	67f821fa-5663-4d69-82c9-5ee13a09f324	3
312134	oxazepam 15 MG Oral Capsule	SCD	67f821fa-5663-4d69-82c9-5ee13a09f324	3
198059	oxazepam 30 MG Oral Capsule	SCD	67f821fa-5663-4d69-82c9-5ee13a09f324	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69315-913-01	69315091301	100 CAPSULE in 1 BOTTLE (69315-913-01)	100 capsule	2025-07-09	No	No	Current