Home NDC 51672-4005-1 Carbamazepine
Product NDC 51672-4005
Requested package NDC 51672-4005-1
11-digit product format 516724005
Labeler code 51672
Product ID 51672-4005_5a4a48b3-c961-591d-e063-6394a90ab81d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA074649
Marketing category ANDA
Marketing start 1996-10-03
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 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 A074649-001 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074649-001 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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 f41ea6bd6efb…
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.
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-4005-1 Carbamazepine 100 in 1 BOTTLE TABLET 100 11 51672-4005-2 Carbamazepine 500 in 1 BOTTLE TABLET 500 11 51672-4005-3 Carbamazepine 1000 in 1 BOTTLE TABLET 1000 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Carbamazepine ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 Carbamazepine ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 aluminum oxide INACTIVE INGREDIENT LMI26O6933 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 diethyl phthalate INACTIVE INGREDIENT UF064M00AF CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 poloxamer 188 INACTIVE INGREDIENT LQA7B6G8JG CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 potassium sorbate INACTIVE INGREDIENT 1VPU26JZZ4 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 sorbitol INACTIVE INGREDIENT 506T60A25R CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 starch, corn INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 sucrose INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 water INACTIVE INGREDIENT 059QF0KO0R CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 xanthan gum INACTIVE INGREDIENT TTV12P4NEE CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 Carbamazepine ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 Carbamazepine ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 diethyl phthalate INACTIVE INGREDIENT UF064M00AF CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 Carbamazepine ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] 2 Carbamazepine ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] 2 DIETHYL PHTHALATE INACTIVE INGREDIENT UF064M00AF CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] 2 CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 DIETHYL PHTHALATE INACTIVE INGREDIENT UF064M00AF CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 ETHYLCELLULOSE INACTIVE INGREDIENT 7Z8S9VYZ4B CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4005 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 9 Current NDC, Legacy NDC, 3 package rows 20241127_0526a054-3eda-49b4-b390-7d5d16e30af8.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carbamazepine CARBAMAZEPINE A-S Medication Solutions 1dc2a4d3-2ebc-4c9b-a347-92acd9f231f2 2026-06-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074649 application number: ANDA074649 Carbamazepine CARBAMAZEPINE Golden State Medical Supply, Inc. 8a1ce79d-18ea-f30b-e053-2995a90ad1fb 2026-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074649 application number: ANDA074649 Carbamazepine CARBAMAZEPINE Bryant Ranch Prepack 2d2c5317-4072-477b-a4e2-f6765fc71657 2025-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074649 application number: ANDA074649 Carbamazepine CARBAMAZEPINE Aphena Pharma Solutions - Tennessee, LLC 697f3e5a-c84b-44a6-b9f3-15e7d9bb6395 2024-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074649 application number: ANDA074649
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 51672-4005-1 51672400501 100 TABLET in 1 BOTTLE (51672-4005-1) 100 tablet 1996-10-03 0000-00-00 No No Current