Carbamazepine

Product NDC: 62332-422
Requested package NDC: 62332-422-31
11-digit product format: 623320422
Labeler code: 62332
Product ID: 62332-422_e1678991-b726-4e47-bb00-98c9d7277a1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA219939
Marketing category: ANDA
Marketing start: 2025-07-26
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: 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
A219939-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25
A219939-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25
A219939-003	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219939-001	AB
A219939-002	AB
A219939-003	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.

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	A219939-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219939-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219939-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219939-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219939-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219939-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219939-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219939-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219939-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219939-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219939-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219939-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219939-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219939-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219939-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219939-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219939-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219939-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-07-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219939-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219939-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219939-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219939-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219939-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219939-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219939-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219939-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219939-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219939-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219939-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219939-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219939-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219939-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219939-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219939-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219939-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219939-003	AB	1	`a50c72e98297…`

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: 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199378	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
726a127b-03b2-44e8-a63d-078b35e27525	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
62332-422-31	Carbamazepine	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		5
62332-422-91	Carbamazepine	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62332-422-31	EA - Each	62332-422	1333aa94-bfca-435c-9722-eb1c4176ea10	1	2026-05-22

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Alembic Pharmaceuticals Inc.	726a127b-03b2-44e8-a63d-078b35e27525	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219939 application number: ANDA219939 ndc (package): 62332-422-31 ndc (product): 62332-422 ndc11 (package): 62332042231
Carbamazepine	CARBAMAZEPINE	Alembic Pharmaceuticals Limited	1fc170d7-db1a-486d-8c10-faa6e3da3b1e	2025-07-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219939 application number: ANDA219939

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	726a127b-03b2-44e8-a63d-078b35e27525	5
402505	carBAMazepine 200 MG 12HR Extended Release Oral Tablet	PSN	726a127b-03b2-44e8-a63d-078b35e27525	5
402506	carBAMazepine 400 MG 12HR Extended Release Oral Tablet	PSN	726a127b-03b2-44e8-a63d-078b35e27525	5
199378	12 HR carbamazepine 100 MG Extended Release Oral Tablet	SCD	726a127b-03b2-44e8-a63d-078b35e27525	5
402505	12 HR carbamazepine 200 MG Extended Release Oral Tablet	SCD	726a127b-03b2-44e8-a63d-078b35e27525	5
402506	12 HR carbamazepine 400 MG Extended Release Oral Tablet	SCD	726a127b-03b2-44e8-a63d-078b35e27525	5
199378	carbamazepine 100 MG 12 HR Extended Release Oral Tablet	SY	726a127b-03b2-44e8-a63d-078b35e27525	5
402505	carbamazepine 200 MG 12 HR Extended Release Oral Tablet	SY	726a127b-03b2-44e8-a63d-078b35e27525	5
402506	carbamazepine 400 MG 12 HR Extended Release Oral Tablet	SY	726a127b-03b2-44e8-a63d-078b35e27525	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62332-422-31	62332042231	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-422-31)	2025-07-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	2025-10-31	Human Prescription Drug Label	5