Home NDC 68788-9812 Carbamazepine
Product NDC 68788-9812
11-digit product format 687889812
Labeler code 68788
Product ID 68788-9812_b387be7e-e619-46b5-a7cc-2fcc0484e30a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Preferred Pharmaceuticals, Inc
Application ANDA075687
Marketing category ANDA
Marketing start 2012-04-23
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 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 3 · 132 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075687-001 CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 A075687-002 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075687-001 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 3 · 88 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 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB RS 2000-10-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB RS 2000-10-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB RS 2000-10-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 68788-9812-1 Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL 68788-9812-2 Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL 68788-9812-3 Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL 68788-9812-6 Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL 68788-9812-9 Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-9812-1 Carbamazepine 100 in 1 BOTTLE TABLET, CHEWABLE 100 3 68788-9812-2 Carbamazepine 20 in 1 BOTTLE TABLET, CHEWABLE 20 3 68788-9812-3 Carbamazepine 30 in 1 BOTTLE TABLET, CHEWABLE 30 3 68788-9812-6 Carbamazepine 60 in 1 BOTTLE TABLET, CHEWABLE 60 3 68788-9812-9 Carbamazepine 90 in 1 BOTTLE TABLET, CHEWABLE 90 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Carbamazepine ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 Carbamazepine ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 aluminum oxide INACTIVE INGREDIENT LMI26O6933 CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 diethyl phthalate INACTIVE INGREDIENT UF064M00AF CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 sorbitol INACTIVE INGREDIENT 506T60A25R CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9812 CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC] 3 Legacy NDC, 5 package rows 20140402_157f67bd-74f0-4d68-9058-8fa707c564be.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68788-9812-1 68788981201 100 in 1 BOTTLE Historical 68788-9812-2 68788981202 20 in 1 BOTTLE Historical 68788-9812-3 68788981203 30 in 1 BOTTLE Historical 68788-9812-6 68788981206 60 in 1 BOTTLE Historical 68788-9812-9 68788981209 90 in 1 BOTTLE Historical