Carbamazepine

Product NDC: 67046-086
11-digit product format: 670460086
Labeler code: 67046
Product ID: 67046-086_8e06995c-26c9-4ef3-9421-16a2360db628
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA070541
Marketing category: ANDA
Marketing start: 2010-02-24
Marketing end: 0000-00-00
Substance: CARBAMAZEPINE
Active strength: 200 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: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67046-086		I	Inactivated by FDA	2026-08-11
excluded package	package	67046-086	67046-086-30	I	Inactivated by FDA	2026-08-11
excluded package	package	67046-086	67046-086-60	I	Inactivated by FDA	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-086-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-086-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-086-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-086-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-086-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-086-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-086-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-086-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-086-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-086-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-086-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-086-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-086-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-086-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67046-086-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67046-086-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67046-086-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67046-086-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67046-086-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67046-086-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67046-086-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67046-086-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67046-086-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67046-086-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67046-086-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67046-086-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67046-086-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67046-086-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67046-086-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67046-086-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67046-086-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67046-086-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67046-086-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67046-086-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67046-086-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67046-086-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67046-086-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67046-086-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67046-086-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67046-086-30	`e2bbac7714bc…`	`27bdfed8d636…`

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
A070541-001	EPITOL	CARBAMAZEPINE	200MG	TABLET / ORAL	AB		1986-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070541-001	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	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`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	A070541-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070541-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070541-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070541-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070541-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070541-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070541-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070541-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070541-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070541-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070541-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070541-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070541-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070541-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070541-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070541-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070541-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070541-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070541-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070541-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070541-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070541-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070541-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070541-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070541-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070541-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070541-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070541-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070541-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070541-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070541-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070541-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070541-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070541-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070541-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070541-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070541-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070541-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070541-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070541-001	AB	1	`cb3db0bc1861…`

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
67046-086-30	2019-10-21	C162847	48780-1	956f9ecf-c447-621f-e053-dbdaa90a74ad	CARBAMAZEPINE TABLETS USP, 200 mg/CARBAMAZEPINE CHEWABLE TABLETS USP, 100 mg 0109 0778 Rx only
67046-086-60	2019-10-21	C162847	48780-1	956f9ecf-c447-621f-e053-dbdaa90a74ad	CARBAMAZEPINE TABLETS USP, 200 mg/CARBAMAZEPINE CHEWABLE TABLETS USP, 100 mg 0109 0778 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-086-30	Carbamazepine	30 in 1 BLISTER PACK	TABLET	30		1
67046-086-60	Carbamazepine	60 in 1 BLISTER PACK	TABLET	60		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ETHYLCELLULOSE	INACTIVE INGREDIENT	7Z8S9VYZ4B	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-086	CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 2 package rows	20100226_8e06995c-26c9-4ef3-9421-16a2360db628.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
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	ebcffad6-da03-43f4-a75b-7de13e94bb7d	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070541 application number: ANDA070541

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
308979	carBAMazepine 200 MG Oral Tablet	PSN	8e06995c-26c9-4ef3-9421-16a2360db628	1
308979	carbamazepine 200 MG Oral Tablet	SCD	8e06995c-26c9-4ef3-9421-16a2360db628	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67046-086-30	67046008630	30 in 1 BLISTER PACK	Historical
67046-086-60	67046008660	60 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBAMAZEPINE TABLETS USP, 200 mg/CARBAMAZEPINE CHEWABLE TABLETS USP, 100 mg 0109 0778 Rx only	Contract Pharmacy Services-PA	2010-02-24	HUMAN PRESCRIPTION DRUG LABEL	1