Carbatrol

Product NDC: 54092-171
11-digit product format: 540920171
Labeler code: 54092
Product ID: 54092-171_39171a32-c78d-4130-be53-638e19cf2261
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbamazepine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA020712
Marketing category: NDA
Marketing start: 1999-12-22
Substance: CARBAMAZEPINE
Active strength: 100 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
N020712-001	CARBATROL	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30
N020712-002	CARBATROL	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30
N020712-003	CARBATROL	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020712-001	AB
N020712-002	AB
N020712-003	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	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`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	N020712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020712-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	100 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200131	Internal RxNorm lookup
200133	Internal RxNorm lookup
308977	Internal RxNorm lookup
313931	Internal RxNorm lookup
388311	Internal RxNorm lookup
404742	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
bc03e499-5bac-4293-bff4-6864153a624d	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
54092-171-12	Carbatrol	120 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	120		39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-171-12	EA - Each	54092-171	9fd13434-8441-4bf9-9d0a-9092987bee92	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]	26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54092-171	CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]	38	Current NDC, Legacy NDC, 1 package rows	20230422_bc03e499-5bac-4293-bff4-6864153a624d.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
Carbatrol	CARBAMAZEPINE	Takeda Pharmaceuticals America, Inc.	bc03e499-5bac-4293-bff4-6864153a624d	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020712 application number: NDA020712 ndc (product): 54092-171

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
388311	carBAMazepine 100 MG 12HR Extended Release Oral Capsule	PSN	bc03e499-5bac-4293-bff4-6864153a624d	39
200133	carBAMazepine 200 MG 12HR Extended Release Oral Capsule	PSN	bc03e499-5bac-4293-bff4-6864153a624d	39
200131	carBAMazepine 300 MG 12HR Extended Release Oral Capsule	PSN	bc03e499-5bac-4293-bff4-6864153a624d	39
404742	Carbatrol 100 MG 12HR Extended Release Oral Capsule	PSN	bc03e499-5bac-4293-bff4-6864153a624d	39
308977	Carbatrol 200 MG 12HR Extended Release Oral Capsule	PSN	bc03e499-5bac-4293-bff4-6864153a624d	39
313931	Carbatrol 300 MG 12HR Extended Release Oral Capsule	PSN	bc03e499-5bac-4293-bff4-6864153a624d	39
404742	12 HR carbamazepine 100 MG Extended Release Oral Capsule [Carbatrol]	SBD	bc03e499-5bac-4293-bff4-6864153a624d	39
308977	12 HR carbamazepine 200 MG Extended Release Oral Capsule [Carbatrol]	SBD	bc03e499-5bac-4293-bff4-6864153a624d	39
313931	12 HR carbamazepine 300 MG Extended Release Oral Capsule [Carbatrol]	SBD	bc03e499-5bac-4293-bff4-6864153a624d	39
388311	12 HR carbamazepine 100 MG Extended Release Oral Capsule	SCD	bc03e499-5bac-4293-bff4-6864153a624d	39
200133	12 HR carbamazepine 200 MG Extended Release Oral Capsule	SCD	bc03e499-5bac-4293-bff4-6864153a624d	39
200131	12 HR carbamazepine 300 MG Extended Release Oral Capsule	SCD	bc03e499-5bac-4293-bff4-6864153a624d	39
404742	12 HR Carbatrol 100 MG Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39
308977	12 HR Carbatrol 200 MG Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39
313931	12 HR Carbatrol 300 MG Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39
388311	carbamazepine 100 MG 12 HR Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39
200133	carbamazepine 200 MG 12 HR Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39
200131	carbamazepine 300 MG 12 HR Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39
404742	Carbatrol 100 MG 12 HR Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39
308977	Carbatrol 200 MG 12 HR Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39
313931	Carbatrol 300 MG 12 HR Extended Release Oral Capsule	SY	bc03e499-5bac-4293-bff4-6864153a624d	39

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-171-12	54092017112	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12)	1999-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBATROL ® (carbamazepine) Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only	Takeda Pharmaceuticals America, Inc. \| Patheon Manufacturing Services LLC \| Jubilant Pharmova Limited	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	39