Carbamazepine

Product NDC
21695-724
11-digit product format
216950724
Labeler code
21695
Product ID
21695-724_fc51bad7-8a77-4c0e-9ff8-fa3474796d35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074649
Marketing category
ANDA
Marketing start
2009-07-01
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
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-724IInactivated by FDA2026-08-11
excluded packagepackage21695-72421695-724-30IInactivated by FDA2026-08-11
excluded packagepackage21695-72421695-724-60IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-724-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-724-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-724-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-724-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-724-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-724-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-724-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-724-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-724-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-724-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-724-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-724-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-724-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-724-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-724-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-724-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-724-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-724-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-724-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-724-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-724-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-724-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-724-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-724-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-724-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-724-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-724-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-724-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-724-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-724-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-724-30fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-724-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-724-3086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-724-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-724-30bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-724-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-724-308dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-724-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-724-30e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-724-60e2bbac7714bc…27bdfed8d636…

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
A074649-001CARBAMAZEPINECARBAMAZEPINE200MGTABLET / ORALAB1996-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074649-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-033f01610625f2…
2019-09-15 20:21 UTC2019-09A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074649-001CARBAMAZEPINE200MGTABLET / ORALAB1996-10-03cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074649-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074649-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074649-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074649-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074649-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074649-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074649-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074649-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074649-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074649-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074649-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074649-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074649-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074649-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074649-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074649-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074649-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074649-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074649-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074649-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074649-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074649-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074649-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074649-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074649-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074649-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074649-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074649-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074649-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074649-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074649-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074649-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074649-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074649-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074649-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074649-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074649-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074649-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074649-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074649-001AB1cb3db0bc1861…

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
21695-724-302019-09-24C16284748780-1934fe258-4ba2-48b1-e053-8cdaa90a720aCARBAMAZEPINE TABLETS USP 200 mg Rx only
21695-724-602019-09-24C16284748780-1934fe258-4ba2-48b1-e053-8cdaa90a720aCARBAMAZEPINE TABLETS USP 200 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-724-30Carbamazepine30 in 1 BOTTLETABLET302
21695-724-60Carbamazepine60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-724-30EA - Each21695-724226f7077-a23b-43f0-81b0-ebea7280a24412012-07-24
21695-724-60EA - Each21695-724333523d1-69c9-485d-8ba4-2e34180f5ca212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-724CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20111108_25cca2b1-9020-4d8a-bc22-b8063e57f9e1.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.40bf2923-24b1-4af1-8d20-03cf06b455a52026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074649
application number: ANDA074649
CarbamazepineCARBAMAZEPINEA-S Medication Solutions1dc2a4d3-2ebc-4c9b-a347-92acd9f231f22026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074649
application number: ANDA074649
CarbamazepineCARBAMAZEPINEGolden State Medical Supply, Inc.8a1ce79d-18ea-f30b-e053-2995a90ad1fb2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074649
application number: ANDA074649
CarbamazepineCARBAMAZEPINESun Pharmaceutical Industries, Inc.0526a054-3eda-49b4-b390-7d5d16e30af82026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074649
application number: ANDA074649
CarbamazepineCARBAMAZEPINEPD-Rx Pharmaceuticals, Inc.ce5aec7a-e161-46bf-8fc0-afb41689e59a2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074649
application number: ANDA074649
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack2d2c5317-4072-477b-a4e2-f6765fc716572025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074649
application number: ANDA074649
CarbamazepineCARBAMAZEPINENCS HealthCare of KY, LLC dba Vangard Labs10c9795e-358c-4f6a-b7bc-cccc179617c02024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074649
application number: ANDA074649
CarbamazepineCARBAMAZEPINEAphena Pharma Solutions - Tennessee, LLC697f3e5a-c84b-44a6-b9f3-15e7d9bb63952024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074649
application number: ANDA074649

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN25cca2b1-9020-4d8a-bc22-b8063e57f9e12
308979carbamazepine 200 MG Oral TabletSCD25cca2b1-9020-4d8a-bc22-b8063e57f9e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-724-302169507243030 in 1 BOTTLEHistorical
21695-724-602169507246060 in 1 BOTTLEHistorical