Topamax

Product NDC
21695-129
11-digit product format
216950129
Labeler code
21695
Product ID
21695-129_202b1a2a-11dc-4c3d-aa53-27512a98a042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020505
Marketing category
NDA
Marketing start
1997-01-01
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
50 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-129IInactivated by FDA2026-10-12
excluded packagepackage21695-12921695-129-15IInactivated by FDA2026-10-12

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 1 · 44 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 packagepackage21695-129-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-129-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-129-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-129-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-129-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-129-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-129-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-129-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-129-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-129-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-129-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-129-15557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-129-158af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-129-15834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-129-151332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-129-15fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-129-1586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-129-15bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-129-158dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-129-15e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-129-159bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-129-15110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020505-001TOPAMAXTOPIRAMATE100MGTABLET / ORALABRLD, RS1996-12-24
N020505-002TOPAMAXTOPIRAMATE200MGTABLET / ORALABRLD1996-12-24
N020505-003TOPAMAXTOPIRAMATE300MGTABLET / ORAL1996-12-24
N020505-004TOPAMAXTOPIRAMATE25MGTABLET / ORALABRLD1996-12-24
N020505-005TOPAMAXTOPIRAMATE50MGTABLET / ORALABRLD1996-12-24
N020505-006TOPAMAXTOPIRAMATE400MGTABLET / ORAL1996-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020505-001AB
N020505-002AB
N020505-004AB
N020505-005AB

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 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-003TOPAMAX300MGTABLET / ORAL1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-2484e616aacf4f…
2026-09-14 22:38:342026-08N020505-006TOPAMAX400MGTABLET / ORAL1996-12-2484e616aacf4f…
2026-08-18 06:07:402026-07N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020505-006TOPAMAX400MGTABLET / ORAL1996-12-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020505-006TOPAMAX400MGTABLET / ORAL1996-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-003TOPAMAX300MGTABLET / ORAL1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020505-006TOPAMAX400MGTABLET / ORAL1996-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-003TOPAMAX300MGTABLET / ORAL1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020505-006TOPAMAX400MGTABLET / ORAL1996-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-005TOPAMAX50MGTABLET / ORALABRLD1996-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020505-006TOPAMAX400MGTABLET / ORAL1996-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-001TOPAMAX100MGTABLET / ORALABRLD, RS1996-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-002TOPAMAX200MGTABLET / ORALABRLD1996-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-003TOPAMAX300MGTABLET / ORAL1996-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020505-004TOPAMAX25MGTABLET / ORALABRLD1996-12-24b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020505-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020505-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020505-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020505-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020505-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020505-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020505-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020505-005AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020505-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020505-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020505-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020505-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020505-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020505-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020505-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020505-005AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020505-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020505-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020505-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020505-005AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020505-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020505-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020505-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020505-005AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020505-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020505-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020505-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020505-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020505-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020505-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020505-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020505-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020505-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020505-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020505-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020505-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020505-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020505-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020505-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020505-005AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedcProduct name420260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077Product name220250623
cb966f54-bbf0-40fb-b581-80c6648d510cProduct name420250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193Product name420250305
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-129-15Topamax15 in 1 BOTTLETABLET, COATED151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-129-15EA - Each21695-12988c30944-3b2d-41b2-822b-d19ba286a73112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-129TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110104_202b1a2a-11dc-4c3d-aa53-27512a98a042.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151228Topamax 100 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855Topamax 25 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227Topamax 50 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
199889topiramate 100 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
199888topiramate 25 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151226topiramate 50 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151228topiramate 100 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855topiramate 25 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227topiramate 50 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
199889topiramate 100 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
199888topiramate 25 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151226topiramate 50 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151228Topamax 100 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855Topamax 25 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227Topamax 50 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-129-152169501291515 in 1 BOTTLEHistorical