Carbamazepine

Product NDC
50268-170
11-digit product format
502680170
Labeler code
50268
Product ID
50268-170_47e2efaa-df8e-5401-e063-6394a90aae6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA078986
Marketing category
ANDA
Marketing start
2021-10-19
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
A078986-001CARBAMAZEPINECARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25
A078986-002CARBAMAZEPINECARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25
A078986-003CARBAMAZEPINECARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078986-001AB
A078986-002AB
A078986-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078986-002CARBAMAZEPINE200MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078986-003CARBAMAZEPINE300MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078986-001CARBAMAZEPINE100MGCAPSULE, EXTENDED RELEASE / ORALAB2011-11-258072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078986-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078986-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078986-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078986-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078986-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078986-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078986-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078986-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078986-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078986-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078986-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078986-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078986-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078986-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078986-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078986-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078986-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078986-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078986-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078986-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078986-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078986-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078986-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078986-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078986-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078986-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078986-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078986-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078986-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078986-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078986-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078986-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078986-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078986-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078986-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078986-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078986-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078986-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078986-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078986-001AB18072bd15b7f6…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200131Internal RxNorm lookup
200133Internal RxNorm lookup
388311Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ceb84aa4-2041-6e6e-e053-2995a90a0f24Available 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
50268-170-11Carbamazepine1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE14
50268-170-13Carbamazepine30 in 1 BOXCAPSULE, EXTENDED RELEASE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-170-11EA - Each50268-17081b0f8b7-0b7b-4097-bce9-2b59418f18a412021-11-09
50268-170-13EA - Each50268-170752aa59c-df0e-44b0-85a9-d918295c4e5212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-170CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_ceb84aa4-2041-6e6e-e053-2995a90a0f24.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEMajor Pharmaceuticals2676f950-48b4-4bef-a792-ea4570de9aa62026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack47d0ea82-9974-4d41-9ae1-5f1b11419a332026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEAvPAKceb84aa4-2041-6e6e-e053-2995a90a0f242026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
ndc (product): 50268-170
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackd684dfd8-1e0d-47a1-bf37-ada6413815f22025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack0ccee1ed-3d7c-452b-9519-c1ddb92893df2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack1a8c4f15-9e75-4919-ac67-06102b82dd922025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.e9d282f0-8bb7-4280-b83d-b70d83a04b932025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEApotex Corp.e91f9de3-3fdd-0a6b-71ce-53a2cc1428162025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack46eef194-760d-43ea-86c5-341927277c912025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack4db57051-13bb-4038-ae58-e4d7f541450d2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack34f75728-b9e8-48e7-e063-6394a90afc312025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078986
application number: ANDA078986

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-170-11502680170111 in 1 BLISTER PACKHistorical
50268-170-135026801701330 BLISTER PACK in 1 BOX (50268-170-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-170-11) 30 blister pack2021-10-190000-00-00NoNoCurrent