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 43 .
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 · 86 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 2026-09-14 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…2019-12-13 00:20 UTC 2019-12 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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
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.
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