Home NDC 0121-0862-30 Carbamazepine
Product NDC 0121-0862
Requested package NDC 0121-0862-30
11-digit product format 001210862
Labeler code 0121
Product ID 0121-0862_6480cf3e-b4a0-4dfc-b505-6c74bcddcdff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form SUSPENSION
Route ORAL
Labeler PAI Holdings, LLC
Application ANDA075714
Marketing category ANDA
Marketing start 2002-06-05
Marketing end 0000-00-00
Substance CARBAMAZEPINE
Active strength 100 mg/5mL
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 2023-12-31
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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0121-0862-30 00121086230 3 TRAY in 1 CASE (0121-0862-30) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0862-05) 3 tray 2020-05-14 0000-00-00 No No Current