Home NDC 60429-934 Carbamazepine
Product NDC 60429-934
11-digit product format 604290934
Labeler code 60429
Product ID 60429-934_4b3312bc-fde8-8277-e063-6394a90a17b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA075687
Marketing category ANDA
Marketing start 2000-10-24
Substance CARBAMAZEPINE
Active strength 100 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075687-001 CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 A075687-002 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075687-001 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 3 · 82 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 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB RS 2000-10-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB RS 2000-10-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB RS 2000-10-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB 2000-10-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB RS 2000-10-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075687-001 CARBAMAZEPINE 100MG TABLET, CHEWABLE / ORAL AB RS 2000-10-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075687-002 CARBAMAZEPINE 200MG TABLET, CHEWABLE / ORAL RS 2002-07-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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/1
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 308973 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 60429-934-05 Carbamazepine 500 in 1 BOTTLE TABLET, CHEWABLE 500 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60429-934 CARBAMAZEPINE TABLET, CHEWABLE [GOLDEN STATE MEDICAL SUPPLY, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20250119_536811ab-308b-4866-9185-9e4149483512.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carbamazepine CARBAMAZEPINE REMEDYREPACK INC. 9471b7fb-29d3-4009-9d0f-f20c27351db5 2026-07-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075687 application number: ANDA075687 Carbamazepine CARBAMAZEPINE REMEDYREPACK INC. d0121be3-b904-41d3-a81a-292aa4176491 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075687 application number: ANDA075687 Carbamazepine CARBAMAZEPINE Golden State Medical Supply, Inc. 536811ab-308b-4866-9185-9e4149483512 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075687 application number: ANDA075687 ndc (product): 60429-934 Carbamazepine CARBAMAZEPINE Sun Pharmaceutical Industries, Inc. 0526a054-3eda-49b4-b390-7d5d16e30af8 2026-01-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075687 application number: ANDA075687 Carbamazepine CARBAMAZEPINE NCS HealthCare of KY, LLC dba Vangard Labs 963db7cf-e9f5-496c-816e-626e89bc839e 2022-08-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075687 application number: ANDA075687
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60429-934-05 60429093405 500 TABLET, CHEWABLE in 1 BOTTLE (60429-934-05) 2011-07-20 0000-00-00 No No Current