Carbamazepine

Product NDC
75834-221
Requested package NDC
75834-221-00
11-digit product format
758340221
Labeler code
75834
Product ID
75834-221_45806c19-4811-987e-e063-6394a90aa8fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
NIVAGEN PHARMACEUTICALS, INC.
Application
ANDA207798
Marketing category
ANDA
Marketing start
2020-04-21
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207798-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET / ORALBX2020-04-15
A207798-002CARBAMAZEPINECARBAMAZEPINE200MGTABLET / ORALBX2020-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207798-001BX
A207798-002BX

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-1587673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207798-001BX1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207798-002BX1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207798-001BX131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207798-002BX131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207798-001BX16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207798-002BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207798-001BX1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207798-002BX1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207798-001BX1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207798-002BX1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207798-001BX103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207798-002BX103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207798-001BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207798-002BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207798-001BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207798-002BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207798-001BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207798-002BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207798-001BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207798-002BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207798-001BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207798-002BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207798-001BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207798-002BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207798-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207798-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207798-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207798-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207798-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207798-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207798-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207798-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207798-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207798-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207798-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207798-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207798-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207798-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207798-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207798-002AB187673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
Carbamazepine
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197441Internal RxNorm lookup
308979Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e68998cb-5f91-4d7e-85a6-555efb8b0384Available 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
75834-221-00Carbamazepine1000 in 1 BOTTLETABLET100020
75834-221-01Carbamazepine100 in 1 BOTTLETABLET10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-221-00EA - Each75834-221b4462764-affe-48c8-bf37-779cae4d27a512020-06-05
75834-221-01EA - Each75834-221c425f8ed-ebf2-45f7-9acd-60a31e75ed0112020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-221CARBAMAZEPINE TABLET [NIVAGEN PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 2 package rows20241225_e68998cb-5f91-4d7e-85a6-555efb8b0384.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9f3d91cd-a959-4e07-a51b-8a4e9ba9ece22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINECoupler LLC544e3b55-c8a3-a480-e063-6394a90abbb52026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.f3465f71-8931-43b6-baea-eac7046a44002026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack62d38b93-7dd0-48e7-bd59-a434d52520f62026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINEPreferred Pharmaceuticals Inc.867a5f4d-8ae6-4339-bbb4-0bf62fb082e52026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINENIVAGEN PHARMACEUTICALS, INC.e68998cb-5f91-4d7e-85a6-555efb8b03842025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
ndc (package): 75834-221-00
ndc (product): 75834-221
ndc11 (package): 75834022100
CarbamazepineCARBAMAZEPINEA-S Medication Solutions047bc284-060a-4db9-bf37-75d10f95a0a62025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CARBAMAZEPINECARBAMAZEPINEdirect rxb56dd9c8-1bca-21e3-e053-2995a90a3e6e2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN62d38b93-7dd0-48e7-bd59-a434d52520f6105
308979carbamazepine 200 MG Oral TabletSCD62d38b93-7dd0-48e7-bd59-a434d52520f6105
197441carBAMazepine 100 MG Oral TabletPSNe68998cb-5f91-4d7e-85a6-555efb8b038420
308979carBAMazepine 200 MG Oral TabletPSNe68998cb-5f91-4d7e-85a6-555efb8b038420
197441carbamazepine 100 MG Oral TabletSCDe68998cb-5f91-4d7e-85a6-555efb8b038420
308979carbamazepine 200 MG Oral TabletSCDe68998cb-5f91-4d7e-85a6-555efb8b038420
308979carBAMazepine 200 MG Oral TabletPSN9f3d91cd-a959-4e07-a51b-8a4e9ba9ece217
308979carbamazepine 200 MG Oral TabletSCD9f3d91cd-a959-4e07-a51b-8a4e9ba9ece217
308979carBAMazepine 200 MG Oral TabletPSN047bc284-060a-4db9-bf37-75d10f95a0a67
308979carbamazepine 200 MG Oral TabletSCD047bc284-060a-4db9-bf37-75d10f95a0a67
308979carBAMazepine 200 MG Oral TabletPSN867a5f4d-8ae6-4339-bbb4-0bf62fb082e56
308979carbamazepine 200 MG Oral TabletSCD867a5f4d-8ae6-4339-bbb4-0bf62fb082e56
308979carBAMazepine 200 MG Oral TabletPSNb56dd9c8-1bca-21e3-e053-2995a90a3e6e2
308979carbamazepine 200 MG Oral TabletSCDb56dd9c8-1bca-21e3-e053-2995a90a3e6e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-221-00758340221001000 TABLET in 1 BOTTLE (75834-221-00) 1000 tablet2020-04-210000-00-00NoNoCurrent