Carbamazepine

Product NDC
51672-4041
11-digit product format
516724041
Labeler code
51672
Product ID
51672-4041_48fd19fc-5d5b-0d24-e063-6294a90a0aa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, 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-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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2019-12-13 00:20 UTC2019-12A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2000-10-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALABRS2000-10-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075687-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALABRS2000-10-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A075687-002CARBAMAZEPINE200MGTABLET, CHEWABLE / ORALRS2002-07-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-10-28 04:53 UTC2022-10A075687-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075687-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075687-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Carbamazepine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33CM23913MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197442Internal RxNorm lookup
199378Internal RxNorm lookup
308973Internal RxNorm lookup
308976Internal RxNorm lookup
308979Internal RxNorm lookup
402505Internal RxNorm lookup
402506Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0526a054-3eda-49b4-b390-7d5d16e30af8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4041-0Carbamazepine10 in 1 CARTONTABLET, CHEWABLE1011
51672-4041-0Carbamazepine10 in 1 BLISTER PACKTABLET, CHEWABLE1011
51672-4041-1Carbamazepine100 in 1 BOTTLETABLET, CHEWABLE10011
51672-4041-2Carbamazepine500 in 1 BOTTLETABLET, CHEWABLE50011
51672-4041-9Carbamazepine5 in 1 CARTONTABLET, CHEWABLE511
51672-4041-9Carbamazepine10 in 1 BLISTER PACKTABLET, CHEWABLE1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4041-1EA - Each51672-40414c98a79e-6df5-45c1-b739-16327bfed6db12012-07-24
51672-4041-2EA - Each51672-4041a1d44adc-0326-41e4-8a02-61090671263912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarbamazepineACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
CarbamazepineACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
aluminum oxideINACTIVE INGREDIENTLMI26O6933CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
diethyl phthalateINACTIVE INGREDIENTUF064M00AFCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
sorbitolINACTIVE INGREDIENT506T60A25RCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
sucroseINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
waterINACTIVE INGREDIENT059QF0KO0RCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
xanthan gumINACTIVE INGREDIENTTTV12P4NEECARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
51672-4041CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 6 package rows20241127_0526a054-3eda-49b4-b390-7d5d16e30af8.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9471b7fb-29d3-4009-9d0f-f20c27351db52026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075687
application number: ANDA075687
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.d0121be3-b904-41d3-a81a-292aa41764912026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075687
application number: ANDA075687
CarbamazepineCARBAMAZEPINEGolden State Medical Supply, Inc.536811ab-308b-4866-9185-9e41494835122026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075687
application number: ANDA075687
CarbamazepineCARBAMAZEPINESun Pharmaceutical Industries, Inc.0526a054-3eda-49b4-b390-7d5d16e30af82026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075687
application number: ANDA075687
ndc (product): 51672-4041
CarbamazepineCARBAMAZEPINENCS HealthCare of KY, LLC dba Vangard Labs963db7cf-e9f5-496c-816e-626e89bc839e2022-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075687
application number: ANDA075687

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSNd0121be3-b904-41d3-a81a-292aa417649119
308973carbamazepine 100 MG Chewable TabletSCDd0121be3-b904-41d3-a81a-292aa417649119
308973carBAMazepine 100 MG Chewable TabletPSN9471b7fb-29d3-4009-9d0f-f20c27351db513
308973carbamazepine 100 MG Chewable TabletSCD9471b7fb-29d3-4009-9d0f-f20c27351db513
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
308973carBAMazepine 100 MG Chewable TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
308976carBAMazepine 100 MG in 5 mL Oral SuspensionPSN0526a054-3eda-49b4-b390-7d5d16e30af811
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
197442carBAMazepine 200 MG Chewable TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
308979carBAMazepine 200 MG Oral TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
308973carbamazepine 100 MG Chewable TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
308976carbamazepine 20 MG/ML Oral SuspensionSCD0526a054-3eda-49b4-b390-7d5d16e30af811
197442carbamazepine 200 MG Chewable TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
308979carbamazepine 200 MG Oral TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY0526a054-3eda-49b4-b390-7d5d16e30af811
308976carbamazepine 100 MG per 5 ML Oral SuspensionSY0526a054-3eda-49b4-b390-7d5d16e30af811
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY0526a054-3eda-49b4-b390-7d5d16e30af811
308976carbamazepine 200 MG per 10 ML Oral SuspensionSY0526a054-3eda-49b4-b390-7d5d16e30af811
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY0526a054-3eda-49b4-b390-7d5d16e30af811
308973carBAMazepine 100 MG Chewable TabletPSN536811ab-308b-4866-9185-9e414948351210
308973carbamazepine 100 MG Chewable TabletSCD536811ab-308b-4866-9185-9e414948351210
308973carBAMazepine 100 MG Chewable TabletPSN963db7cf-e9f5-496c-816e-626e89bc839e4
308973carbamazepine 100 MG Chewable TabletSCD963db7cf-e9f5-496c-816e-626e89bc839e4
197441carBAMazepine 100 MG Oral TabletPSN6903e7ef-8b5c-4b64-a87d-62f1f102bc751
308979carBAMazepine 200 MG Oral TabletPSN6903e7ef-8b5c-4b64-a87d-62f1f102bc751
197441carbamazepine 100 MG Oral TabletSCD6903e7ef-8b5c-4b64-a87d-62f1f102bc751
308979carbamazepine 200 MG Oral TabletSCD6903e7ef-8b5c-4b64-a87d-62f1f102bc751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4041-05167240410010 BLISTER PACK in 1 CARTON (51672-4041-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK10 blister pack2000-10-240000-00-00NoNoCurrent
51672-4041-151672404101100 TABLET, CHEWABLE in 1 BOTTLE (51672-4041-1) 2000-10-240000-00-00NoNoCurrent
51672-4041-251672404102500 TABLET, CHEWABLE in 1 BOTTLE (51672-4041-2) 2000-10-240000-00-00NoNoCurrent
51672-4041-9516724041095 BLISTER PACK in 1 CARTON (51672-4041-9) / 10 TABLET, CHEWABLE in 1 BLISTER PACK5 blister pack2000-10-240000-00-00NoNoCurrent