Carbamazepine

Product NDC: 70518-4682
Requested package NDC: 70518-4682-0
11-digit product format: 705184682
Labeler code: 70518
Product ID: 70518-4682_5bff528e-924d-b9c8-e063-6394a90a5ad4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA213284
Marketing category: ANDA
Marketing start: 2026-06-25
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213284-001	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	AB		2022-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213284-001	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	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213284-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2022-08-22	`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	A213284-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213284-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213284-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213284-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213284-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213284-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213284-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213284-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213284-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213284-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213284-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213284-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213284-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213284-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213284-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213284-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213284-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213284-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213284-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213284-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213284-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213284-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213284-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213284-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213284-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213284-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213284-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213284-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213284-001	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	200 mg/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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Unichem Pharmaceuticals (USA), Inc.	50ba2042-fc67-4266-a773-a30f07649a5a	2026-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213284 application number: ANDA213284
Carbamazepine	CARBAMAZEPINE	NuCare Pharmaceuticals, Inc.	509bd024-9944-a2f3-e063-6394a90ae4cb	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213284 application number: ANDA213284

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33CM23913M	CARBAMAZEPINE	298-46-4	CARBAMAZEPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4682-0	70518468200	30 TABLET in 1 BLISTER PACK (70518-4682-0)	30 tablet	2026-06-25	No	No	Current