Home NDC 68094-125 Carbamazepine
Product NDC 68094-125
11-digit product format 680940125
Labeler code 68094
Product ID 68094-125_73dd0c6b-0e35-4cf3-98e0-32b565797d04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form SUSPENSION
Route ORAL
Labeler Precision Dose, Inc.
Application ANDA214277
Marketing category ANDA
Marketing start 2026-10-09
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 2027-12-31
Current FDA listing Yes 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 A214277-001 CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214277-001 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.
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 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214277-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2022-10-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 100 mg/5mL
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carbamazepine CARBAMAZEPINE ANI Pharmaceuticals, Inc. e006049f-1c0c-4544-969e-0344d1b8c5ba 2026-01-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214277 application number: ANDA214277
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68094-125-62 68094012562 3 TRAY in 1 CASE (68094-125-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-125-59) 3 tray 2026-10-09 No No Current