CARBAMAZEPINE

Product NDC: 17856-0029
Requested package NDC: 17856-0029-1
11-digit product format: 178560029
Labeler code: 17856
Product ID: 17856-0029_8fe5545e-d942-4062-bb81-7b554b58ef6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbamazepine
Dosage form: SUSPENSION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA075714
Marketing category: ANDA
Marketing start: 2002-06-05
Marketing end: 0000-00-00
Substance: CARBAMAZEPINE
Active strength: 100 mg/5mL
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17856-0029	17856-0029-1	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 1 · 18 matching rows.

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

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

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
A075714-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB		2002-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075714-001	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	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`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	A075714-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075714-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075714-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075714-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075714-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075714-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075714-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075714-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075714-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075714-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075714-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075714-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075714-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075714-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075714-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075714-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075714-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075714-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075714-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075714-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075714-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075714-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075714-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075714-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075714-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075714-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075714-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075714-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075714-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075714-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075714-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075714-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075714-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075714-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075714-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075714-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075714-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075714-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075714-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075714-001	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
2275add5-bc9e-431c-8e27-74c11f3127d5	Product name	1	20200728
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
7c710123-0208-426b-be07-b37720f2767d	Product name	1	20161206
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
17856-0029-1	2024-01-30	C162847	48780-1	d6a99b39-bcd0-a426-e053-dadaa90af4c2	CARBAMAZEPINE - carbamazepine suspension Morton Grove Pharmaceuticals, Inc. Rx only
17856-0029-1	2022-09-26	C162847	48780-1	d6a99b39-bcd0-a426-e053-dadaa90af4c2	CARBAMAZEPINE - carbamazepine suspension Morton Grove Pharmaceuticals, Inc. Rx only
17856-0029-1	2022-01-28	C162847	48780-1	d6a99b39-bcd0-a426-e053-dadaa90af4c2	CARBAMAZEPINE - carbamazepine suspension Morton Grove Pharmaceuticals, Inc. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0029-1	CARBAMAZEPINE	72 in 1 BOX, UNIT-DOSE	SUSPENSION	72		2
17856-0029-2	CARBAMAZEPINE	10 mL in 1 CUP, UNIT-DOSE	SUSPENSION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0029	CARBAMAZEPINE SUSPENSION [ATLANTIC BIOLOGICALS CORP.]	2	Legacy NDC, 2 package rows	20220927_364aa931-f090-406b-8e79-c44e7592520e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Chartwell Governmental & Specialty RX, LLC.	35298eaf-3478-4dfb-a629-298dd52713f0	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075714 application number: ANDA075714
Carbamazepine	CARBAMAZEPINE	Chartwell RX, LLC	8d5ace90-983b-48c4-baf1-b44f6af146de	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075714 application number: ANDA075714

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
308976	carBAMazepine 100 MG in 5 mL Oral Suspension	PSN	364aa931-f090-406b-8e79-c44e7592520e	2
308976	carbamazepine 20 MG/ML Oral Suspension	SCD	364aa931-f090-406b-8e79-c44e7592520e	2
308976	carbamazepine 100 MG per 5 ML Oral Suspension	SY	364aa931-f090-406b-8e79-c44e7592520e	2
308976	carbamazepine 200 MG per 10 ML Oral Suspension	SY	364aa931-f090-406b-8e79-c44e7592520e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0029-1	17856002901	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0029-1) > 10 mL in 1 CUP, UNIT-DOSE (17856-0029-2)	2022-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBAMAZEPINE - carbamazepine suspension Morton Grove Pharmaceuticals, Inc. Rx only	ATLANTIC BIOLOGICALS CORP.	2022-09-26	HUMAN PRESCRIPTION DRUG LABEL	2