Home NDC 62135-867-24 Carbamazepine
Product NDC 62135-867
Requested package NDC 62135-867-24
11-digit product format 621350867
Labeler code 62135
Product ID 62135-867_199bb366-8124-4f1f-e063-6294a90a231b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form SUSPENSION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA075714
Marketing category ANDA
Marketing start 2002-06-05
Substance CARBAMAZEPINE
Active strength 200 mg/10mL
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 2026-12-31
Current FDA listing Yes 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 A075714-001 CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075714-001 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 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 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.
Additional Listing Data#
Finished product Yes
Brand name base Carbamazepine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMAZEPINE 200 mg/10mL
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 308976 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 62135-867-24 Carbamazepine 10 in 1 TRAY SUSPENSION 10 3 62135-867-24 Carbamazepine 2 in 1 BOX SUSPENSION 2 3 62135-867-59 Carbamazepine 10 mL in 1 PACKAGE SUSPENSION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-867 CARBAMAZEPINE SUSPENSION [CHARTWELL RX, LLC] 3 Current NDC, 3 package rows 20240531_8d5ace90-983b-48c4-baf1-b44f6af146de.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 Sample Exclude flag Status 62135-867-24 62135086724 2 TRAY in 1 BOX (62135-867-24) / 10 PACKAGE in 1 TRAY / 10 mL in 1 PACKAGE (62135-867-59) 2 tray 2024-05-28 No No Current