Home NDC 70518-2242 Carbamazepine
Product NDC 70518-2242
11-digit product format 705182242
Labeler code 70518
Product ID 70518-2242_5c8b178a-bc40-26f5-e063-6394a90ae036
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA074649
Marketing category ANDA
Marketing start 2019-07-31
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 · 57 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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A074649-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074649-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074649-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A074649-001 AB 1 a50c72e98297…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2242 CARBAMAZEPINE TABLET [REMEDYREPACK INC.] 15 Current NDC, Legacy NDC, 9 package rows 20250309_40bf2923-24b1-4af1-8d20-03cf06b455a5.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 70518-2242-0 70518224200 180 TABLET in 1 BOTTLE, PLASTIC (70518-2242-0) 180 tablet 2019-07-31 0000-00-00 No No Current 70518-2242-1 70518224201 1 POUCH in 1 BOX, UNIT-DOSE (70518-2242-1) > 1 TABLET in 1 POUCH (70518-2242-2) 1 pouch 2019-10-19 0000-00-00 No No Current 70518-2242-2 70518224202 1 in 1 POUCH Historical 70518-2242-3 70518224203 30 TABLET in 1 BLISTER PACK (70518-2242-3) 30 tablet 2020-08-19 0000-00-00 No No Current 70518-2242-4 70518224204 100 POUCH in 1 BOX (70518-2242-4) > 1 TABLET in 1 POUCH (70518-2242-5) 100 pouch 2021-11-26 0000-00-00 No No Current 70518-2242-5 70518224205 1 in 1 POUCH Historical 70518-2242-6 70518224206 100 POUCH in 1 BOX (70518-2242-6) / 1 TABLET in 1 POUCH (70518-2242-7) 100 pouch 2022-04-07 0000-00-00 No No Current 70518-2242-7 70518224207 1 in 1 POUCH Historical 70518-2242-8 70518224208 60 in 1 BLISTER PACK Historical