FDA.reportPublic FDA data

Carbamazepine

Product NDC
72664-218
11-digit product format
726640218
Labeler code
72664
Product ID
72664-218_ca8bfc0a-d43b-1072-e053-2995a90a66f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
VGYAAN Pharmaceuticals LLC
Application
ANDA214328
Marketing category
ANDA
Marketing start
2022-01-03
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72664-218IInactivated by FDA2026-08-07
excluded packagepackage72664-21872664-218-01IInactivated by FDA2026-08-07
excluded packagepackage72664-21872664-218-10IInactivated by FDA2026-08-07
excluded packagepackage72664-21872664-218-30IInactivated by FDA2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214328-001CARBAMAZEPINECARBAMAZEPINE200MGTABLET / ORAL2021-08-16

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 UTC2026-02A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-164b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214328-001CARBAMAZEPINE200MGTABLET / ORALAB2021-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214328-001CARBAMAZEPINE200MGTABLET / ORALAB2021-08-16782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-03-09 01:35 UTC2022-03A214328-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214328-001AB1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72664-218-012026-01-29C16284748780-149896155-aba7-586f-e063-e6dba90add90Carbamazepine Tablets USP, 200 mg Rx only
72664-218-102026-01-29C16284748780-149896155-aba7-586f-e063-e6dba90add90Carbamazepine Tablets USP, 200 mg Rx only
72664-218-302026-01-29C16284748780-149896155-aba7-586f-e063-e6dba90add90Carbamazepine Tablets USP, 200 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72664-218-01Carbamazepine100 in 1 BOTTLETABLET1006
72664-218-10Carbamazepine1000 in 1 BOTTLETABLET10006
72664-218-30Carbamazepine30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72664-218CARBAMAZEPINE TABLET [VGYAAN PHARMACEUTICALS LLC]6Legacy NDC, 3 package rows20230923_6626654b-6af4-4fc0-83df-08d6438a6beb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN6626654b-6af4-4fc0-83df-08d6438a6beb6
308979carbamazepine 200 MG Oral TabletSCD6626654b-6af4-4fc0-83df-08d6438a6beb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72664-218-0172664021801100 TABLET in 1 BOTTLE (72664-218-01) 100 tablet2022-01-030000-00-00NoNoCurrent
72664-218-10726640218101000 TABLET in 1 BOTTLE (72664-218-10) 1000 tablet2022-01-030000-00-00NoNoCurrent
72664-218-307266402183030 TABLET in 1 BOTTLE (72664-218-30) 30 tablet2022-01-030000-00-00NoNoCurrent