FDA.reportPublic FDA data

Carbamazepine

Product NDC
13668-284
11-digit product format
136680284
Labeler code
13668
Product ID
13668-284_025fe6a0-10f7-423b-a08c-716b2227789a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA212524
Marketing category
ANDA
Marketing start
2025-09-10
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212524-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13
A212524-002CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13
A212524-003CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A212524-001AB
A212524-002AB
A212524-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212524-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212524-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212524-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212524-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORALAB2025-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212524-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORALAB2025-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212524-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORALAB2025-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212524-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORALAB2025-01-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212524-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORALAB2025-01-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212524-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORALAB2025-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212524-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212524-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212524-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212524-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212524-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212524-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212524-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212524-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212524-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212524-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212524-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212524-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212524-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212524-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212524-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212524-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212524-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212524-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212524-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212524-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212524-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212524-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212524-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212524-003AB1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212524-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212524-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212524-003AB1a50c72e98297…

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c4860c1-daba-4e0f-97fd-d30cbc8603a2Available on FDA.report

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
13668-284-01Carbamazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
13668-284-05Carbamazepine500 in 1 BOTTLETABLET, EXTENDED RELEASE5007
13668-284-22Carbamazepine8 in 1 BLISTER PACKTABLET, EXTENDED RELEASE87
13668-284-23Carbamazepine80 in 1 CARTONTABLET, EXTENDED RELEASE807
13668-284-30Carbamazepine30 in 1 BOTTLETABLET, EXTENDED RELEASE307
13668-284-60Carbamazepine60 in 1 BOTTLETABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-284-01EA - Each13668-284810cd4ed-a1ae-476f-97c4-69e0887d09b012026-02-05

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
CarbamazepineCARBAMAZEPINETorrent Pharmaceuticals Limited7c4860c1-daba-4e0f-97fd-d30cbc8603a22026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212524
application number: ANDA212524
ndc (product): 13668-284

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN7c4860c1-daba-4e0f-97fd-d30cbc8603a27
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN7c4860c1-daba-4e0f-97fd-d30cbc8603a27
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN7c4860c1-daba-4e0f-97fd-d30cbc8603a27
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD7c4860c1-daba-4e0f-97fd-d30cbc8603a27
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD7c4860c1-daba-4e0f-97fd-d30cbc8603a27
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD7c4860c1-daba-4e0f-97fd-d30cbc8603a27
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY7c4860c1-daba-4e0f-97fd-d30cbc8603a27
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY7c4860c1-daba-4e0f-97fd-d30cbc8603a27
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY7c4860c1-daba-4e0f-97fd-d30cbc8603a27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-284-0113668028401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-284-01) 2025-09-10NoNoCurrent
13668-284-0513668028405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-284-05) 2025-09-10NoNoCurrent
13668-284-22136680284228 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (13668-284-22) 2025-09-10NoNoCurrent
13668-284-231366802842380 TABLET, EXTENDED RELEASE in 1 CARTON (13668-284-23) 2025-09-10NoNoCurrent
13668-284-301366802843030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-284-30) 2025-09-10NoNoCurrent
13668-284-601366802846060 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-284-60) 2025-09-10NoNoCurrent