Topiramate

Product NDC
12634-452
11-digit product format
126340452
Labeler code
12634
Product ID
12634-452_35d19524-1c96-64e5-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
25 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
No
Listing certified through
2019-12-31
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 · 44 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct12634-452IInactivated by FDA2026-08-03
excluded productproduct12634-452DDiscontinued by firm2026-08-03
excluded packagepackage12634-45212634-452-00IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-01IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-09IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-40IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-42IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-45IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-50IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-52IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-54IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-57IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-59IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-60IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-61IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-63IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-66IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-67IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-69IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-71IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-74IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-78IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-79IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-80IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-81IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-82IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-84IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-85IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-90IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-91IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-92IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-93IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-94IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-95IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-96IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-97IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-98IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-99IInactivated by FDA2026-08-03
excluded packagepackage12634-45212634-452-01DDiscontinued by firm2026-08-03
excluded packagepackage12634-45212634-452-60DDiscontinued by firm2026-08-03
excluded packagepackage12634-45212634-452-71DDiscontinued by firm2026-08-03
excluded packagepackage12634-45212634-452-78DDiscontinued by firm2026-08-03
excluded packagepackage12634-45212634-452-80DDiscontinued by firm2026-08-03
excluded packagepackage12634-45212634-452-85DDiscontinued by firm2026-08-03

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 15 · 861 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-50IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-85IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-95IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-63IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-92IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-91IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-84IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-74IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-45IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-80IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-78DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-94IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-42IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-96IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-52IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-61IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-69IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-57IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-79IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-78IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-00IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-71IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-67IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-93IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-99IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-81IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-98IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-60DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-09IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-59IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-54IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-71DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-66IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-40IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-82IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-97IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-85DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-452-80DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-50IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-85IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-95IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-63IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-92IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-91IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-84IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-74IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-45IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-80IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-78DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-94IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-452-42IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…

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

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
A090278-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A090278-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A090278-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A090278-004TOPIRAMATETOPIRAMATE200MGTABLET / ORAL2009-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090278-001AB
A090278-002AB
A090278-003AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-004TOPIRAMATE200MGTABLET / ORAL2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090278-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090278-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090278-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-003AB179d66fd596c7…

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#

NDC, Related label table
NDCRelated label
12634-452-00These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-01These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-09These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-40These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-42These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-45These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-50These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-52These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-54These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-57These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-59These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-60These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-61These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-63These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-66These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-67These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-69These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-71These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-74These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-78These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-79These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-80These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-81These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-82These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-84These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-85These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-90These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-91These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-92These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-93These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-94These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-95These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-96These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-97These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-98These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
12634-452-99These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-452-00Topiramate10 in 1 BOTTLETABLET103
12634-452-01Topiramate100 in 1 BOTTLETABLET1003
12634-452-09Topiramate35 in 1 BOTTLETABLET353
12634-452-40Topiramate40 in 1 BOTTLETABLET403
12634-452-42Topiramate42 in 1 BOTTLETABLET423
12634-452-45Topiramate45 in 1 BOTTLETABLET453
12634-452-50Topiramate50 in 1 BOTTLETABLET503
12634-452-52Topiramate12 in 1 BLISTER PACKTABLET123
12634-452-54Topiramate14 in 1 BLISTER PACKTABLET143
12634-452-57Topiramate20 in 1 BLISTER PACKTABLET203
12634-452-59Topiramate30 in 1 BLISTER PACKTABLET303
12634-452-60Topiramate60 in 1 BOTTLETABLET603
12634-452-61Topiramate10 in 1 BLISTER PACKTABLET103
12634-452-63Topiramate3 in 1 BLISTER PACKTABLET33
12634-452-66Topiramate6 in 1 BLISTER PACKTABLET63
12634-452-67Topiramate7 in 1 BLISTER PACKTABLET73
12634-452-69Topiramate9 in 1 BLISTER PACKTABLET93
12634-452-71Topiramate30 in 1 BOTTLETABLET303
12634-452-74Topiramate24 in 1 BOTTLETABLET243
12634-452-78Topiramate28 in 1 BOTTLETABLET283
12634-452-79Topiramate25 in 1 BOTTLETABLET253
12634-452-80Topiramate20 in 1 BOTTLETABLET203
12634-452-81Topiramate21 in 1 BOTTLETABLET213
12634-452-82Topiramate12 in 1 BOTTLETABLET123
12634-452-84Topiramate14 in 1 BOTTLETABLET143
12634-452-85Topiramate15 in 1 BOTTLETABLET153
12634-452-90Topiramate90 in 1 BOTTLETABLET903
12634-452-91Topiramate1 in 1 BLISTER PACKTABLET13
12634-452-92Topiramate2 in 1 BOTTLETABLET23
12634-452-93Topiramate3 in 1 BOTTLETABLET33
12634-452-94Topiramate4 in 1 BOTTLETABLET43
12634-452-95Topiramate5 in 1 BOTTLETABLET53
12634-452-96Topiramate6 in 1 BOTTLETABLET63
12634-452-97Topiramate7 in 1 BOTTLETABLET73
12634-452-98Topiramate8 in 1 BOTTLETABLET83
12634-452-99Topiramate9 in 1 BOTTLETABLET93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-452TOPIRAMATE TABLET [APOTHECA INC.]3Legacy NDC, 36 package rows20160622_35d19524-1c95-64e5-e054-00144ff88e88.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e846124d-e9e6-42c7-83f1-5df170d3f70b2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack47ef2964-3a41-4bfd-86fb-d44560b9961f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack484c132f-3d3d-4218-b22f-82e9b56cc2f42026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.1b847969-2124-4350-94b0-ef5ba707673b2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.021005ab-6a00-40d8-9aee-20c91613b4d52026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.3c909a53-ae66-4b28-a741-b60bb25a69cf2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack61390be3-7553-4cb5-b5da-7571ed7d4b172024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepackffaacad8-4594-45a8-b292-02a84cd0c35b2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATENuCare Pharmaceuticals,Inc.9ddb8451-a455-87ec-e053-2995a90a5e5e2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LP8bd03bb2-3b9b-4707-a9a4-5618ddc3832f2023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TOPIRAMATETOPIRAMATEProficient Rx LPa30c583a-4b0a-43a6-ae76-19b1a5e916ca2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LPe382a731-ef73-4990-bc74-ffc3a91ff3ba2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LP7d6752ce-7a56-4b04-ab15-cbd40aa5cc942019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef2018-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN35d19524-1c95-64e5-e054-00144ff88e883
199888topiramate 25 MG Oral TabletSCD35d19524-1c95-64e5-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-452-001263404520010 in 1 BOTTLEHistorical
12634-452-0112634045201100 in 1 BOTTLEHistorical
12634-452-091263404520935 in 1 BOTTLEHistorical
12634-452-401263404524040 in 1 BOTTLEHistorical
12634-452-421263404524242 in 1 BOTTLEHistorical
12634-452-451263404524545 in 1 BOTTLEHistorical
12634-452-501263404525050 in 1 BOTTLEHistorical
12634-452-521263404525212 in 1 BLISTER PACKHistorical
12634-452-541263404525414 in 1 BLISTER PACKHistorical
12634-452-571263404525720 in 1 BLISTER PACKHistorical
12634-452-591263404525930 in 1 BLISTER PACKHistorical
12634-452-601263404526060 in 1 BOTTLEHistorical
12634-452-611263404526110 in 1 BLISTER PACKHistorical
12634-452-63126340452633 in 1 BLISTER PACKHistorical
12634-452-66126340452666 in 1 BLISTER PACKHistorical
12634-452-67126340452677 in 1 BLISTER PACKHistorical
12634-452-69126340452699 in 1 BLISTER PACKHistorical
12634-452-711263404527130 in 1 BOTTLEHistorical
12634-452-741263404527424 in 1 BOTTLEHistorical
12634-452-781263404527828 in 1 BOTTLEHistorical
12634-452-791263404527925 in 1 BOTTLEHistorical
12634-452-801263404528020 in 1 BOTTLEHistorical
12634-452-811263404528121 in 1 BOTTLEHistorical
12634-452-821263404528212 in 1 BOTTLEHistorical
12634-452-841263404528414 in 1 BOTTLEHistorical
12634-452-851263404528515 in 1 BOTTLEHistorical
12634-452-901263404529090 in 1 BOTTLEHistorical
12634-452-91126340452911 in 1 BLISTER PACKHistorical
12634-452-92126340452922 in 1 BOTTLEHistorical
12634-452-93126340452933 in 1 BOTTLEHistorical
12634-452-94126340452944 in 1 BOTTLEHistorical
12634-452-95126340452955 in 1 BOTTLEHistorical
12634-452-96126340452966 in 1 BOTTLEHistorical
12634-452-97126340452977 in 1 BOTTLEHistorical
12634-452-98126340452988 in 1 BOTTLEHistorical
12634-452-99126340452999 in 1 BOTTLEHistorical