Carbamazepine

Product NDC: 72162-1715
11-digit product format: 721621715
Labeler code: 72162
Product ID: 72162-1715_34f755de-a8e8-df2d-e063-6294a90acaae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078986
Marketing category: ANDA
Marketing start: 2012-03-23
Substance: CARBAMAZEPINE
Active strength: 300 mg/1
Pharmacologic classes: Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
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 43.

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
A078986-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25
A078986-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25
A078986-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078986-001	AB
A078986-002	AB
A078986-003	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.

Product history page 1 of 4 · 129 observed 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
2026-09-14 22:38:34	2026-08	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078986-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078986-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078986-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078986-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078986-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078986-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078986-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078986-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078986-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078986-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078986-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078986-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078986-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078986-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078986-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078986-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33CM23913M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200131	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
34f75728-b9e8-48e7-e063-6394a90afc31	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
26452c40-1589-928d-2fae-b84a1d1cf183	Product name	9	20251105
2275add5-bc9e-431c-8e27-74c11f3127d5	Product name	1	20200728
7c710123-0208-426b-be07-b37720f2767d	Product name	1	20161206
8448f819-8511-2a70-1d0e-32e16eac918d	Product name	1	20140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-1715-2	Carbamazepine	120 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	120		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1715-2	EA - Each	72162-1715	d3c1c21e-111b-4250-8ff7-c594602f9ed2	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1715	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	100	Current NDC, 1 package rows	20250514_34f75728-b9e8-48e7-e063-6394a90afc31.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Apotex Corp.	e91f9de3-3fdd-0a6b-71ce-53a2cc142816	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Major Pharmaceuticals	2676f950-48b4-4bef-a792-ea4570de9aa6	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	47d0ea82-9974-4d41-9ae1-5f1b11419a33	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	AvPAK	ceb84aa4-2041-6e6e-e053-2995a90a0f24	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	d684dfd8-1e0d-47a1-bf37-ada6413815f2	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	0ccee1ed-3d7c-452b-9519-c1ddb92893df	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	1a8c4f15-9e75-4919-ac67-06102b82dd92	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	46eef194-760d-43ea-86c5-341927277c91	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	4db57051-13bb-4038-ae58-e4d7f541450d	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	34f75728-b9e8-48e7-e063-6394a90afc31	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986 ndc (product): 72162-1715

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33CM23913M	CARBAMAZEPINE	298-46-4	CARBAMAZEPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200131	carBAMazepine 300 MG 12HR Extended Release Oral Capsule	PSN	34f75728-b9e8-48e7-e063-6394a90afc31	100
200131	12 HR carbamazepine 300 MG Extended Release Oral Capsule	SCD	34f75728-b9e8-48e7-e063-6394a90afc31	100
200131	carbamazepine 300 MG 12 HR Extended Release Oral Capsule	SY	34f75728-b9e8-48e7-e063-6394a90afc31	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-1715-2	72162171502	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1715-2)	2025-05-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only	Bryant Ranch Prepack	2025-05-12	HUMAN PRESCRIPTION DRUG LABEL	100