FDA.reportPublic FDA data

Carbamazepine

Product NDC
27241-232
11-digit product format
272410232
Labeler code
27241
Product ID
27241-232_f2790e0b-b9ad-4c14-99dc-1516a4716082
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA216193
Marketing category
ANDA
Marketing start
2023-03-24
Substance
CARBAMAZEPINE
Active strength
200 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
2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216193-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24
A216193-002CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24
A216193-003CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24

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 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-248072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216193-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216193-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216193-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216193-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216193-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216193-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A216193-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A216193-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A216193-003AB1053a50430f4f…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199378Internal 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
2e3c4854-89a1-4e3f-88d4-e164829585fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-232-01Carbamazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-232CARBAMAZEPINE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.]2Current NDC, 1 package rows20240125_2e3c4854-89a1-4e3f-88d4-e164829585fb.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEAjanta Pharma USA Inc.2e3c4854-89a1-4e3f-88d4-e164829585fb2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216193
application number: ANDA216193
ndc (product): 27241-232

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN2e3c4854-89a1-4e3f-88d4-e164829585fb2
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN2e3c4854-89a1-4e3f-88d4-e164829585fb2
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN2e3c4854-89a1-4e3f-88d4-e164829585fb2
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD2e3c4854-89a1-4e3f-88d4-e164829585fb2
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD2e3c4854-89a1-4e3f-88d4-e164829585fb2
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD2e3c4854-89a1-4e3f-88d4-e164829585fb2
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY2e3c4854-89a1-4e3f-88d4-e164829585fb2
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY2e3c4854-89a1-4e3f-88d4-e164829585fb2
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY2e3c4854-89a1-4e3f-88d4-e164829585fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-232-0127241023201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-232-01) 2023-03-24NoNoCurrent