Carbamazepine

Product NDC: 51672-4124
11-digit product format: 516724124
Labeler code: 51672
Product ID: 51672-4124_48fd19fc-5d5b-0d24-e063-6294a90a0aa0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA078115
Marketing category: ANDA
Marketing start: 2009-03-31
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 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
A078115-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31
A078115-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31
A078115-003	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078115-001	AB
A078115-002	AB
A078115-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078115-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078115-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078115-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2009-03-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078115-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078115-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078115-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078115-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078115-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078115-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078115-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078115-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078115-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078115-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078115-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078115-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078115-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078115-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078115-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078115-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078115-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078115-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078115-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078115-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078115-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078115-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078115-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078115-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078115-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078115-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078115-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078115-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078115-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078115-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078115-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078115-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078115-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078115-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078115-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078115-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078115-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078115-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078115-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078115-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carbamazepine
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 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197442	Internal RxNorm lookup
199378	Internal RxNorm lookup
308973	Internal RxNorm lookup
308976	Internal RxNorm lookup
308979	Internal RxNorm lookup
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
0526a054-3eda-49b4-b390-7d5d16e30af8	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
2275add5-bc9e-431c-8e27-74c11f3127d5	Product name	1	20200728
7c710123-0208-426b-be07-b37720f2767d	Product name	1	20161206
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
8448f819-8511-2a70-1d0e-32e16eac918d	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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	SPL version
51672-4124-1	Carbamazepine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	11
51672-4124-3	Carbamazepine	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	11
51672-4124-6	Carbamazepine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4124-1	EA - Each	51672-4124	32278918-29bd-4684-9096-abd16c60f01e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Carbamazepine	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
Carbamazepine	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
diethyl phthalate	INACTIVE INGREDIENT	UF064M00AF	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
poloxamer 188	INACTIVE INGREDIENT	LQA7B6G8JG	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
sorbitol	INACTIVE INGREDIENT	506T60A25R	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
sucrose	INACTIVE INGREDIENT	C151H8M554	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4124	CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	9	Current NDC, Legacy NDC, 3 package rows	20241127_0526a054-3eda-49b4-b390-7d5d16e30af8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	1922a7cd-6a43-dab5-e063-6294a90a3d8f	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078115 application number: ANDA078115
Carbamazepine	CARBAMAZEPINE	Sun Pharmaceutical Industries, Inc.	0526a054-3eda-49b4-b390-7d5d16e30af8	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078115 application number: ANDA078115 ndc (product): 51672-4124
Carbamazepine	CARBAMAZEPINE	Coupler, LLC	30b75584-3a1c-c125-e063-6294a90acaa7	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078115 application number: ANDA078115

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
199378	carBAMazepine 100 MG 12HR Extended Release Oral Tablet	PSN	0526a054-3eda-49b4-b390-7d5d16e30af8	11
308973	carBAMazepine 100 MG Chewable Tablet	PSN	0526a054-3eda-49b4-b390-7d5d16e30af8	11
308976	carBAMazepine 100 MG in 5 mL Oral Suspension	PSN	0526a054-3eda-49b4-b390-7d5d16e30af8	11
402505	carBAMazepine 200 MG 12HR Extended Release Oral Tablet	PSN	0526a054-3eda-49b4-b390-7d5d16e30af8	11
197442	carBAMazepine 200 MG Chewable Tablet	PSN	0526a054-3eda-49b4-b390-7d5d16e30af8	11
308979	carBAMazepine 200 MG Oral Tablet	PSN	0526a054-3eda-49b4-b390-7d5d16e30af8	11
402506	carBAMazepine 400 MG 12HR Extended Release Oral Tablet	PSN	0526a054-3eda-49b4-b390-7d5d16e30af8	11
199378	12 HR carbamazepine 100 MG Extended Release Oral Tablet	SCD	0526a054-3eda-49b4-b390-7d5d16e30af8	11
402505	12 HR carbamazepine 200 MG Extended Release Oral Tablet	SCD	0526a054-3eda-49b4-b390-7d5d16e30af8	11
402506	12 HR carbamazepine 400 MG Extended Release Oral Tablet	SCD	0526a054-3eda-49b4-b390-7d5d16e30af8	11
308973	carbamazepine 100 MG Chewable Tablet	SCD	0526a054-3eda-49b4-b390-7d5d16e30af8	11
308976	carbamazepine 20 MG/ML Oral Suspension	SCD	0526a054-3eda-49b4-b390-7d5d16e30af8	11
197442	carbamazepine 200 MG Chewable Tablet	SCD	0526a054-3eda-49b4-b390-7d5d16e30af8	11
308979	carbamazepine 200 MG Oral Tablet	SCD	0526a054-3eda-49b4-b390-7d5d16e30af8	11
199378	carbamazepine 100 MG 12 HR Extended Release Oral Tablet	SY	0526a054-3eda-49b4-b390-7d5d16e30af8	11
308976	carbamazepine 100 MG per 5 ML Oral Suspension	SY	0526a054-3eda-49b4-b390-7d5d16e30af8	11
402505	carbamazepine 200 MG 12 HR Extended Release Oral Tablet	SY	0526a054-3eda-49b4-b390-7d5d16e30af8	11
308976	carbamazepine 200 MG per 10 ML Oral Suspension	SY	0526a054-3eda-49b4-b390-7d5d16e30af8	11
402506	carbamazepine 400 MG 12 HR Extended Release Oral Tablet	SY	0526a054-3eda-49b4-b390-7d5d16e30af8	11
199378	carBAMazepine 100 MG 12HR Extended Release Oral Tablet	PSN	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4
402505	carBAMazepine 200 MG 12HR Extended Release Oral Tablet	PSN	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4
402506	carBAMazepine 400 MG 12HR Extended Release Oral Tablet	PSN	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4
199378	12 HR carbamazepine 100 MG Extended Release Oral Tablet	SCD	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4
402505	12 HR carbamazepine 200 MG Extended Release Oral Tablet	SCD	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4
402506	12 HR carbamazepine 400 MG Extended Release Oral Tablet	SCD	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4
199378	carbamazepine 100 MG 12 HR Extended Release Oral Tablet	SY	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4
402505	carbamazepine 200 MG 12 HR Extended Release Oral Tablet	SY	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4
402506	carbamazepine 400 MG 12 HR Extended Release Oral Tablet	SY	1922a7cd-6a43-dab5-e063-6294a90a3d8f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4124-1	51672412401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-1)	2009-03-31	0000-00-00	No	No	Current
51672-4124-3	51672412403	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-3)	2009-03-31	0000-00-00	No	No	Current
51672-4124-6	51672412406	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-6)	2009-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg	Golden State Medical Supply, Inc.	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	4
Carbamazepine	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries Ltd.	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	11
Carbamazepine	REMEDYREPACK INC.	2024-01-04	HUMAN PRESCRIPTION DRUG LABEL	11
Carbamazepine	American Health Packaging	2019-07-31	HUMAN PRESCRIPTION DRUG LABEL	3