Home NDC 51672-4047-9 Carbamazepine
Product NDC 51672-4047
Requested package NDC 51672-4047-9
11-digit product format 516724047
Labeler code 51672
Product ID 51672-4047_48fd19fc-5d5b-0d24-e063-6294a90a0aa0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form SUSPENSION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076729
Marketing category ANDA
Marketing start 2004-09-20
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 2027-12-31
Current FDA listing Yes 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 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51672-4047 51672-4047-9 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076729-001 TERIL CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2004-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076729-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Carbamazepine
Listing expiration 2027-12-31 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 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197442 Internal RxNorm lookup 199378 Internal RxNorm lookup 308973 Internal RxNorm lookup 308976 Internal RxNorm lookup 308979 Internal RxNorm lookup 402505 Internal RxNorm lookup 402506 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 51672-4047-4 Carbamazepine 1 in 1 CARTON SUSPENSION 1 11 51672-4047-4 Carbamazepine 450 mL in 1 BOTTLE SUSPENSION 450 11 51672-4047-9 Carbamazepine 450 mL in 1 BOTTLE SUSPENSION 450 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
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4047 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 · 2 matching rows.
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 51672-4047-9 51672404709 450 mL in 1 BOTTLE (51672-4047-9) 450 ml 2004-09-20 0000-00-00 No No Current