Home NDC 0904-7116 Carbamazepine
Product NDC 0904-7116
11-digit product format 009047116
Labeler code 0904
Product ID 0904-7116_9e970e7f-4af3-43cf-91fa-409c08dc4719
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form SUSPENSION
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA076729
Marketing category ANDA
Marketing start 2004-09-20
Marketing end 0000-00-00
Substance CARBAMAZEPINE
Active strength 100 mg/5mL
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 No
Listing certified through 2022-12-31
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 1 · 2 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 product product 0904-7116 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-7116 0904-7116-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 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 · 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 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076729-001 TERIL 100MG/5ML SUSPENSION / ORAL AB 2004-09-20 caaa826d4ba7…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…
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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7116 CARBAMAZEPINE SUSPENSION [MAJOR PHARMACEUTICALS] 2 Legacy NDC 20240906_9e970e7f-4af3-43cf-91fa-409c08dc4719.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carbamazepine CARBAMAZEPINE Atlantic Biologicals Corps 25939406-a836-43cd-9301-56808e9b31ec 2025-03-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076729 application number: ANDA076729
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7116-01 00904711601 30 CUP in 1 CASE (0904-7116-01) > 10 mL in 1 CUP (0904-7116-66) 30 cup 2004-09-20 0000-00-00 No No Current