Home NDC 50090-0384 Carbamazepine
Product NDC 50090-0384
11-digit product format 500900384
Labeler code 50090
Product ID 50090-0384_f4f5d4ed-0bc4-448f-978e-78c14b4ed486
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
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 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 · 44 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 · 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 · 44 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 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 c2088c7a36db…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…
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.
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
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308979 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-0384-0 2023-02-07 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 50090-0384-1 2023-02-07 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 50090-0384-3 2023-02-07 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 50090-0384-0 2023-01-30 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 50090-0384-1 2023-01-30 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 50090-0384-3 2023-01-30 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
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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-0384-0 50090038400 100 TABLET in 1 BOTTLE (50090-0384-0) 100 tablet 2016-06-29 0000-00-00 No No Current 50090-0384-1 50090038401 60 TABLET in 1 BOTTLE (50090-0384-1) 60 tablet 2016-06-29 0000-00-00 No No Current 50090-0384-3 50090038403 28 TABLET in 1 BOTTLE (50090-0384-3) 28 tablet 2016-06-29 0000-00-00 No No Current