Home NDC 68788-7825 Carbamazepine
Product NDC 68788-7825
11-digit product format 687887825
Labeler code 68788
Product ID 68788-7825_f38ba895-3121-4583-98f8-6954ecd2c8e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA207798
Marketing category ANDA
Marketing start 2021-01-08
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 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207798-001 CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 A207798-002 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 80 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL BX 2020-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL BX 2020-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2020-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2020-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2020-04-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2020-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2020-04-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2020-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2020-04-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2020-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207798-001 CARBAMAZEPINE 100MG TABLET / ORAL AB 2020-04-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207798-002 CARBAMAZEPINE 200MG TABLET / ORAL AB 2020-04-15 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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
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 308979 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-7825-1 Carbamazepine 100 in 1 BOTTLE TABLET 100 6 68788-7825-3 Carbamazepine 30 in 1 BOTTLE TABLET 30 6 68788-7825-6 Carbamazepine 60 in 1 BOTTLE TABLET 60 6 68788-7825-9 Carbamazepine 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7825 CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 4 package rows 20250215_867a5f4d-8ae6-4339-bbb4-0bf62fb082e5.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carbamazepine CARBAMAZEPINE Coupler LLC 544e3b55-c8a3-a480-e063-6394a90abbb5 2026-06-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207798 application number: ANDA207798 Carbamazepine CARBAMAZEPINE Bryant Ranch Prepack 62d38b93-7dd0-48e7-bd59-a434d52520f6 2026-05-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207798 application number: ANDA207798 Carbamazepine CARBAMAZEPINE Preferred Pharmaceuticals Inc. 867a5f4d-8ae6-4339-bbb4-0bf62fb082e5 2026-03-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207798 application number: ANDA207798 ndc (product): 68788-7825 Carbamazepine CARBAMAZEPINE A-S Medication Solutions 047bc284-060a-4db9-bf37-75d10f95a0a6 2025-02-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207798 application number: ANDA207798 CARBAMAZEPINE CARBAMAZEPINE direct rx b56dd9c8-1bca-21e3-e053-2995a90a3e6e 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207798 application number: ANDA207798
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-7825-1 68788782501 100 TABLET in 1 BOTTLE (68788-7825-1) 100 tablet 2021-01-08 0000-00-00 No No Current 68788-7825-3 68788782503 30 TABLET in 1 BOTTLE (68788-7825-3) 30 tablet 2021-01-08 0000-00-00 No No Current 68788-7825-6 68788782506 60 TABLET in 1 BOTTLE (68788-7825-6) 60 tablet 2021-01-08 0000-00-00 No No Current 68788-7825-9 68788782509 90 TABLET in 1 BOTTLE (68788-7825-9) 90 tablet 2021-01-08 0000-00-00 No No Current