CARBAMAZEPINE

Product NDC: 53808-0858
11-digit product format: 538080858
Labeler code: 53808
Product ID: 53808-0858_a1e16d44-3bdd-4efd-bad2-9416a826be83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBAMAZEPINE
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA075712
Marketing category: ANDA
Marketing start: 2013-01-01
Marketing end: 0000-00-00
Substance: CARBAMAZEPINE
Active strength: 100 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0858		I	Inactivated by FDA		2026-08-03
excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 36 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	53808-0858		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0858	53808-0858-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075712-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2001-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075712-001	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.

Product history page 1 of 2 · 41 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	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A075712-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075712-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075712-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075712-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075712-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075712-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075712-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075712-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075712-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075712-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075712-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075712-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075712-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075712-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075712-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075712-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075712-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075712-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075712-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075712-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075712-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075712-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075712-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075712-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075712-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075712-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075712-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075712-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075712-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075712-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075712-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075712-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075712-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075712-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075712-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075712-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075712-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075712-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075712-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075712-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	97e6e175-75e8-437b-b457-ddb1ae4e857d	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	2a8c7366-ce89-47ce-8123-96f26812fca0	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
CARBAMAZEPINE	CARBAMAZEPINE	Coupler LLC	5461e739-0f18-b012-e063-6394a90a6b14	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	c72a0668-7cd7-46a8-86d1-d3c17c4b900f	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
Carbamazepine	CARBAMAZEPINE	American Health Packaging	f8444c23-a74f-4d44-867e-26554dbb882f	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0858-1	2020-01-31	C162847	48780-1	9d75b9d0-ff64-f424-e053-dadaa90a57ce	Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0858-1	CARBAMAZEPINE	30 in 1 BLISTER PACK	TABLET, CHEWABLE	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0858	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2	Legacy NDC, 1 package rows	20140402_1d6698da-dacd-44e3-8af1-976bc7427de1.zip

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
308973	carBAMazepine 100 MG Chewable Tablet	PSN	1d6698da-dacd-44e3-8af1-976bc7427de1	2
308973	carbamazepine 100 MG Chewable Tablet	SCD	1d6698da-dacd-44e3-8af1-976bc7427de1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0858-1	53808085801	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	State of Florida DOH Central Pharmacy	2014-03-07	HUMAN PRESCRIPTION DRUG LABEL	2