Carbamazepine

Product NDC
75834-221
Requested package NDC
75834-221-01
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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 75834-221-01
ndc (product): 75834-221
ndc11 (package): 75834022101
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

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

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
75834-221-0175834022101100 TABLET in 1 BOTTLE (75834-221-01) 100 tablet2020-04-210000-00-00NoNoCurrent