Oxcarbazepine

Product NDC: 71205-411
11-digit product format: 712050411
Labeler code: 71205
Product ID: 71205-411_0f92415d-6d81-4cc1-9a3b-028430951eb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxcarbazepine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077802
Marketing category: ANDA
Marketing start: 2007-10-09
Substance: OXCARBAZEPINE
Active strength: 150 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
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
A077802-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09
A077802-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09
A077802-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077802-001	AB
A077802-002	AB
A077802-003	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
2026-08-01 22:54:32	2026-06	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077802-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077802-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077802-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	51008af2-39ac-546c-e063-6294a90a758f	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	50873ef7-3deb-7386-e063-6394a90a9c19	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a90cd1f1-5258-4b0e-92fd-c4cebe47772b	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Glenmark Pharmaceuticals Inc., USA	1c713b59-a628-42e6-b166-ae71c3913284	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Direct_rx	21b0cc84-b64a-75de-e063-6294a90a9dd0	2024-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	95867dcd-fd0e-4570-987b-d35939f7d7d1	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802 ndc (product): 71205-411

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VZI5B1W380	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312136	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
95867dcd-fd0e-4570-987b-d35939f7d7d1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ca2a6da1-5711-44d0-9e79-c84d4265f98b	Product name	3	20250724
536d5b6b-66f1-478b-2670-88fd15947e3b	Product name	7	20250218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-411-30	Oxcarbazepine	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
71205-411-60	Oxcarbazepine	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
71205-411-90	Oxcarbazepine	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-411-60	EA - Each	71205-411	bf9069b0-fce0-48b7-91cb-c2c4cd634f00	1	2020-04-20
71205-411-90	EA - Each	71205-411	9d328406-a282-47ec-b028-c1b230a4f0df	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-411	OXCARBAZEPINE TABLET, FILM COATED [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 3 package rows	20221111_95867dcd-fd0e-4570-987b-d35939f7d7d1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VZI5B1W380	OXCARBAZEPINE	28721-07-5	OXCARBAZEPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312136	OXcarbazepine 150 MG Oral Tablet	PSN	95867dcd-fd0e-4570-987b-d35939f7d7d1	2
312136	oxcarbazepine 150 MG Oral Tablet	SCD	95867dcd-fd0e-4570-987b-d35939f7d7d1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-411-30	71205041130	30 TABLET, FILM COATED in 1 BOTTLE (71205-411-30)	2020-02-26	0000-00-00	No	No	Current
71205-411-60	71205041160	60 TABLET, FILM COATED in 1 BOTTLE (71205-411-60)	2020-02-26	0000-00-00	No	No	Current
71205-411-90	71205041190	90 TABLET, FILM COATED in 1 BOTTLE (71205-411-90)	2020-02-26	0000-00-00	No	No	Current