Tegretol

Product NDC: 0078-0512
11-digit product format: 000780512
Labeler code: 0078
Product ID: 0078-0512_2765f762-2f4e-4a2b-ac10-cf8149d9a38e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbamazepine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA020234
Marketing category: NDA
Marketing start: 1996-03-25
Substance: CARBAMAZEPINE
Active strength: 400 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 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	RLD / RS	Approval date
N020234-001	TEGRETOL-XR	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25
N020234-002	TEGRETOL-XR	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25
N020234-003	TEGRETOL-XR	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020234-001	AB
N020234-002	AB
N020234-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`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	N020234-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020234-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020234-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020234-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020234-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020234-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020234-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020234-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020234-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020234-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tegretol
Brand name suffix: XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	400 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 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199378	Internal RxNorm lookup
308971	Internal RxNorm lookup
308972	Internal RxNorm lookup
308976	Internal RxNorm lookup
308979	Internal RxNorm lookup
402505	Internal RxNorm lookup
402506	Internal RxNorm lookup
866303	Internal RxNorm lookup
866305	Internal RxNorm lookup
866307	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
8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	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
0078-0512-05	TegretolXR	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0512-05	EA - Each	0078-0512	eadd4576-48b3-4567-95e9-e1161ab7de7c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
SUCROSE	INACTIVE INGREDIENT	C151H8M554	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
WATER	INACTIVE INGREDIENT	059QF0KO0R	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0512	TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	34	Current NDC, Legacy NDC, 1 package rows	20250122_8d409411-aa9f-4f3a-a52c-fbcb0c3ec053.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tegretol	CARBAMAZEPINE	Novartis Pharmaceuticals Corporation	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020234 application number: NDA020234 ndc (product): 0078-0512

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	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308976	carBAMazepine 100 MG in 5 mL Oral Suspension	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
402505	carBAMazepine 200 MG 12HR Extended Release Oral Tablet	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308979	carBAMazepine 200 MG Oral Tablet	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
402506	carBAMazepine 400 MG 12HR Extended Release Oral Tablet	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308971	Tegretol 100 MG in 5 mL Oral Suspension	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308972	Tegretol 200 MG Oral Tablet	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866303	Tegretol XR 100 MG 12HR Extended Release Oral Tablet	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866305	Tegretol XR 200 MG 12HR Extended Release Oral Tablet	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866307	Tegretol XR 400 MG 12HR Extended Release Oral Tablet	PSN	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866303	12 HR carbamazepine 100 MG Extended Release Oral Tablet [Tegretol]	SBD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866305	12 HR carbamazepine 200 MG Extended Release Oral Tablet [Tegretol]	SBD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866307	12 HR carbamazepine 400 MG Extended Release Oral Tablet [Tegretol]	SBD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308971	carbamazepine 20 MG/ML Oral Suspension [Tegretol]	SBD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308972	carbamazepine 200 MG Oral Tablet [Tegretol]	SBD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
199378	12 HR carbamazepine 100 MG Extended Release Oral Tablet	SCD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
402505	12 HR carbamazepine 200 MG Extended Release Oral Tablet	SCD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
402506	12 HR carbamazepine 400 MG Extended Release Oral Tablet	SCD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308976	carbamazepine 20 MG/ML Oral Suspension	SCD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308979	carbamazepine 200 MG Oral Tablet	SCD	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866303	12 HR Tegretol XR 100 MG Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866305	12 HR Tegretol XR 200 MG Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866307	12 HR Tegretol XR 400 MG Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
199378	carbamazepine 100 MG 12 HR Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308976	carbamazepine 100 MG per 5 ML Oral Suspension	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
402505	carbamazepine 200 MG 12 HR Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308976	carbamazepine 200 MG per 10 ML Oral Suspension	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
402506	carbamazepine 400 MG 12 HR Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308971	Tegretol 100 MG per 5 ML Oral Suspension	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308971	Tegretol 20 MG/ML Oral Suspension	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
308972	Tegretol 200 MG Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866303	Tegretol XR 100 MG 12 HR Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866305	Tegretol XR 200 MG 12 HR Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36
866307	Tegretol XR 400 MG 12 HR Extended Release Oral Tablet	SY	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	36

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0512-05	00078051205	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0512-05)	1996-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tegretol	Novartis Pharmaceuticals Corporation	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	38
Tegretol	REMEDYREPACK INC.	2023-10-02	HUMAN PRESCRIPTION DRUG LABEL	3