Topiramate

Product NDC
71335-0047
Requested package NDC
71335-0047-2
11-digit product format
713350047
Labeler code
71335
Product ID
71335-0047_0fe6c993-9e52-4717-ad3e-d3999f42bfbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
Substance
TOPIRAMATE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-004771335-0047-2DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076343-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A076343-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A076343-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A076343-004TOPIRAMATETOPIRAMATE200MGTABLET / ORALAB2009-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076343-001AB
A076343-002AB
A076343-003AB
A076343-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076343-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076343-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076343-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076343-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A076343-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076343-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076343-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0H73WJJ391Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199890Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9cb3c29-098c-405f-a200-b436ac7fa1a2Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0047-1Topiramate30 in 1 BOTTLETABLET3025
71335-0047-2Topiramate60 in 1 BOTTLETABLET6025
71335-0047-3Topiramate90 in 1 BOTTLETABLET9025
71335-0047-4Topiramate120 in 1 BOTTLETABLET12025
71335-0047-5Topiramate28 in 1 BOTTLETABLET2825
71335-0047-6Topiramate20 in 1 BOTTLETABLET2025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0047-1EA - Each71335-0047a77a5a71-6bfd-4b3e-9bd4-e08fba2eeab412018-03-08
71335-0047-2EA - Each71335-00479e61e20d-5d7d-447e-9798-b63c9ca15ed412018-03-08
71335-0047-3EA - Each71335-0047b64c44ba-24bf-4f0b-93fc-df9480d82b0e12018-03-08
71335-0047-4EA - Each71335-0047249d23e7-7861-4318-b614-e0047254d78e12018-03-08
71335-0047-5EA - Each71335-0047de66591f-8e1d-4c1c-921e-4ba6e833767312018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0047TOPIRAMATE TABLET [BRYANT RANCH PREPACK]25Current NDC, Legacy NDC, 6 package rows20240726_e9cb3c29-098c-405f-a200-b436ac7fa1a2.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEREMEDYREPACK INC.c90d81a9-a87b-48b0-8cf1-172b82e301272026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEREMEDYREPACK INC.44095c2b-2e90-45d2-ab45-d0961c41550d2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEREMEDYREPACK INC.b71c09c5-43dd-4d98-9ab6-0b0c99908cac2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEREMEDYREPACK INC.f8aaf403-0e15-4bbb-b88b-253d934396882026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATECoupler LLC55f2aca4-b961-a746-e063-6294a90ae8ce2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEREMEDYREPACK INC.0cf388dc-d8f1-4478-bf5f-e64638ee58012026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEC164cb1f7-1a41-675f-e063-6294a90ae0dd2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEA-S Medication Solutions7f1e4475-6326-47a3-a317-b04b74b7c1092026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEA-S Medication Solutions55e71f43-1cd5-4efc-9641-fda0a09c30f02026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATENorthwind Health Company, LLCca45d478-7214-5bc7-e053-2995a90aa6012026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.1f327383-beb3-4d15-add6-5f1c749f2b3f2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATENuCare Pharmaceuticals, Inc.490f109f-30cb-0790-e054-00144ff88e882025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.9e516204-8f39-43c9-9f7e-d9777586f3212025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e39d2549-b489-426d-b576-741537e112e72025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEA-S Medication Solutionsf16b14a2-297f-4adb-8d7a-5f43785faef72025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEA-S Medication Solutionsea0bcab1-cfe1-491c-875e-8c865449557e2025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATECipla USA Inc.ca4ec248-285d-4066-8f89-5ed0c538c4c92025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEProficient Rx LPd63b64dd-b420-4283-9bac-92ba43c9f4292025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCeca774cf-2e4e-7642-e053-2a95a90a847d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCd8dff98f-185e-77ba-e053-2995a90aed2f2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199890topiramate 200 MG Oral TabletPSNe9cb3c29-098c-405f-a200-b436ac7fa1a225
199890topiramate 200 MG Oral TabletSCDe9cb3c29-098c-405f-a200-b436ac7fa1a225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0047-27133500470260 TABLET in 1 BOTTLE (71335-0047-2) 60 tablet2018-05-040000-00-00NoNoCurrent