Carbamazepine

Product NDC: 72516-020
11-digit product format: 725160020
Labeler code: 72516
Product ID: 72516-020_51cbae90-fd98-2e08-e063-6294a90a1748
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Oryza Pharmaceuticals Inc.
Application: ANDA212948
Marketing category: ANDA
Marketing start: 2026-05-18
Substance: CARBAMAZEPINE
Active strength: 200 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: 2027-12-31
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
A212948-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30
A212948-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30
A212948-003	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212948-001	AB
A212948-002	AB
A212948-003	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 3 · 105 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	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212948-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212948-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212948-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	A212948-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212948-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212948-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212948-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212948-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212948-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212948-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212948-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212948-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212948-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212948-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212948-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212948-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212948-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212948-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212948-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212948-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212948-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212948-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212948-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212948-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212948-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212948-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212948-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212948-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212948-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212948-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212948-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212948-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212948-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212948-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212948-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212948-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212948-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212948-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212948-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212948-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212948-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212948-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212948-001	AB	1	`301d65b070ca…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carbamazepine
Brand name suffix: ER
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	200 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402505	Internal RxNorm lookup
402506	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
34b375d0-68b0-4bd5-8ac9-be043b57e91c	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	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
72516-020-01	CarbamazepineER	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1

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
Carbamazepine ER	CARBAMAZEPINE	Oryza Pharmaceuticals Inc.	34b375d0-68b0-4bd5-8ac9-be043b57e91c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212948 application number: ANDA212948 ndc (product): 72516-020

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
402505	carBAMazepine 200 MG 12HR Extended Release Oral Tablet	PSN	34b375d0-68b0-4bd5-8ac9-be043b57e91c	1
402506	carBAMazepine 400 MG 12HR Extended Release Oral Tablet	PSN	34b375d0-68b0-4bd5-8ac9-be043b57e91c	1
402505	12 HR carbamazepine 200 MG Extended Release Oral Tablet	SCD	34b375d0-68b0-4bd5-8ac9-be043b57e91c	1
402506	12 HR carbamazepine 400 MG Extended Release Oral Tablet	SCD	34b375d0-68b0-4bd5-8ac9-be043b57e91c	1
402505	carbamazepine 200 MG 12 HR Extended Release Oral Tablet	SY	34b375d0-68b0-4bd5-8ac9-be043b57e91c	1
402506	carbamazepine 400 MG 12 HR Extended Release Oral Tablet	SY	34b375d0-68b0-4bd5-8ac9-be043b57e91c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72516-020-01	72516002001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-020-01)	2026-05-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Extended-Release Tablets, USP	Oryza Pharmaceuticals Inc.	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	1