Home NDC 0615-3505-39 Carbamazepine
Product NDC 0615-3505
Requested package NDC 0615-3505-39
11-digit product format 006153505
Labeler code 0615
Product ID 0615-3505_4b5b9199-1ceb-40de-b0c2-321bc299e601
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA070541
Marketing category ANDA
Marketing start 1990-09-30
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 No
Listing certified through 2020-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A070541-001 EPITOL CARBAMAZEPINE 200MG TABLET / ORAL AB 1986-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070541-001 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 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0615-3505-39 00615350539 30 TABLET in 1 BLISTER PACK (0615-3505-39) 30 tablet 1990-09-30 0000-00-00 No No Current