Carbamazepine

Product NDC: 68999-802
11-digit product format: 689990802
Labeler code: 68999
Product ID: 68999-802_41dd08a0-b89b-6ad3-e063-6394a90afdc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: SUSPENSION
Route: ORAL
Labeler: Chartwell Governmental & Specialty RX, LLC.
Application: ANDA075714
Marketing category: ANDA
Marketing start: 2002-06-05
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: 2026-12-31
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
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 · 43 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
2026-09-14 22:38:34	2026-08	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075714-001	CARBAMAZEPINE	100MG/5ML	SUSPENSION / ORAL	AB	2002-06-05	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075714-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075714-001	AB	1	`caaa826d4ba7…`
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…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	100 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308976	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
35298eaf-3478-4dfb-a629-298dd52713f0	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68999-802-24	Carbamazepine	2 in 1 BOX	SUSPENSION	2	1
68999-802-24	Carbamazepine	10 in 1 TRAY	SUSPENSION	10	1
68999-802-45	Carbamazepine	5 mL in 1 CUP	SUSPENSION	5	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	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 ndc (product): 68999-802
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	35298eaf-3478-4dfb-a629-298dd52713f0	1
308976	carbamazepine 20 MG/ML Oral Suspension	SCD	35298eaf-3478-4dfb-a629-298dd52713f0	1
308976	carbamazepine 100 MG per 5 ML Oral Suspension	SY	35298eaf-3478-4dfb-a629-298dd52713f0	1
308976	carbamazepine 200 MG per 10 ML Oral Suspension	SY	35298eaf-3478-4dfb-a629-298dd52713f0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68999-802-24	68999080224	2 TRAY in 1 BOX (68999-802-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-802-45)	2 tray	2025-10-15	No	No	Current
68999-802-45	68999080245	5 mL in 1 CUP	5 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Oral Suspension, USP Rx only Prescribing Information	Chartwell Governmental & Specialty RX, LLC.	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	1