FDA.reportPublic FDA data

Topiramate

Product NDC
0093-7336
11-digit product format
000937336
Labeler code
0093
Product ID
0093-7336_da6731ca-e37e-4727-bc67-acd9d6625cbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076575
Marketing category
ANDA
Marketing start
2009-04-17
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
25 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-7336DDiscontinued by firm2026-07-31
excluded packagepackage0093-73360093-7336-06DDiscontinued by firm2026-07-31

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076575-001TOPIRAMATETOPIRAMATE15MGCAPSULE / ORAL2009-04-17
A076575-002TOPIRAMATETOPIRAMATE25MGCAPSULE / ORAL2009-04-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076575-001TOPIRAMATE15MGCAPSULE / ORAL2009-04-17a50c72e98297…
2026-08-01 22:54:322026-06A076575-002TOPIRAMATE25MGCAPSULE / ORAL2009-04-17a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7336-06EA - Each0093-7336f728dc1d-b0c0-418c-a4f1-0214f312c1db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
AMMONIAINACTIVE INGREDIENT5138Q19F1XTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
GELATININACTIVE INGREDIENT2G86QN327LTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WETOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
SHELLACINACTIVE INGREDIENT46N107B71OTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
SUCROSEINACTIVE INGREDIENTC151H8M554TOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7336-060009373360660 CAPSULE, COATED PELLETS in 1 BOTTLE (0093-7336-06) 2009-04-170000-00-00NoNoCurrent