Carbamazepine

Product NDC
60429-934
Requested package NDC
60429-934-05
11-digit product format
604290934
Labeler code
60429
Product ID
60429-934_5ccff99a-acb3-f8e7-e063-6294a90ae9b6
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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075687-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24
A075687-002CARBAMAZEPINECARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A075687-001AB

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24c2088c7a36db…
2026-10-15 13:18:302026-09A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29c2088c7a36db…
2026-09-14 22:38:342026-08A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-2484e616aacf4f…
2026-09-14 22:38:342026-08A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-2984e616aacf4f…
2026-08-18 06:07:402026-07A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALABRS2000-10-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALABRS2000-10-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALABRS2000-10-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-294b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A075687-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A075687-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A075687-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075687-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075687-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075687-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075687-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075687-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075687-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075687-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075687-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075687-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075687-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075687-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075687-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075687-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075687-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075687-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075687-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075687-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075687-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075687-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075687-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075687-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075687-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075687-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075687-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075687-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075687-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075687-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075687-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075687-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075687-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075687-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075687-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075687-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075687-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075687-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075687-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075687-001AB13a93d1ddd44b…

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
IngredientStrength
CARBAMAZEPINE100 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-934-05Carbamazepine500 in 1 BOTTLETABLET, CHEWABLE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-934-05EA - Each60429-9345ef41afa-e3b2-4bab-b719-04cc30efb57c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-934CARBAMAZEPINE TABLET, CHEWABLE [GOLDEN STATE MEDICAL SUPPLY, INC.]8Current NDC, Legacy NDC, 1 package rows20250119_536811ab-308b-4866-9185-9e4149483512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSN536811ab-308b-4866-9185-9e414948351210
308973carbamazepine 100 MG Chewable TabletSCD536811ab-308b-4866-9185-9e414948351210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-934-0560429093405500 TABLET, CHEWABLE in 1 BOTTLE (60429-934-05) 2011-07-200000-00-00NoNoCurrent