Home NDC 60432-129-16 CARBAMAZEPINE
Product NDC 60432-129
Requested package NDC 60432-129-16
11-digit product format 604320129
Labeler code 60432
Product ID 60432-129_187523ab-0aff-4b96-9677-b3909a620213
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carbamazepine
Dosage form SUSPENSION
Route ORAL
Labeler Morton Grove Pharmaceuticals, Inc.
Application ANDA075714
Marketing category ANDA
Marketing start 2002-06-05
Marketing end 0000-00-00
Substance CARBAMAZEPINE
Active strength 100 mg/5mL
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Carbamazepine ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Carbamazepine ACTIVE MOIETY 33CM23913M CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Anhydrous Citric Acid INACTIVE INGREDIENT XF417D3PSL CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Potassium Sorbate INACTIVE INGREDIENT 1VPU26JZZ4 CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Sorbitol INACTIVE INGREDIENT 506T60A25R CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Sucrose INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Vanillin INACTIVE INGREDIENT CHI530446X CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Water INACTIVE INGREDIENT 059QF0KO0R CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60432-129 CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 14 Legacy NDC 20181222_99e20867-a5eb-4474-b846-619ee45f40b8.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 Marketing end Sample Exclude flag Status 60432-129-16 60432012916 450 mL in 1 BOTTLE, PLASTIC (60432-129-16) 450 ml 2002-06-05 0000-00-00 No No Current