FDA.reportPublic FDA data

topiramate

Product NDC
68382-498
11-digit product format
683820498
Labeler code
68382
Product ID
68382-498_69df5f84-1db1-4eb2-ae32-462137a4d812
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078877
Marketing category
ANDA
Marketing start
2024-10-24
Substance
TOPIRAMATE
Active strength
50 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui205315, 205316, 252413

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
68382-498-14topiramate60 in 1 BOTTLECAPSULE, COATED PELLETS6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-498-14EA - Each68382-498d5363f67-174d-47db-998c-c719a77a14cc12025-02-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
GELATININACTIVE INGREDIENT2G86QN327LTOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
POVIDONEINACTIVE INGREDIENTFZ989GH94ETOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
SUCROSEINACTIVE INGREDIENTC151H8M554TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-498TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS USA INC.]26Current NDC, 1 package rows20250419_e4886adf-199d-4b19-a4ef-75f8f94cb54e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205316topiramate 15 MG Oral CapsulePSNe4886adf-199d-4b19-a4ef-75f8f94cb54e27
205315topiramate 25 MG Oral CapsulePSNe4886adf-199d-4b19-a4ef-75f8f94cb54e27
252413topiramate 50 MG Oral CapsulePSNe4886adf-199d-4b19-a4ef-75f8f94cb54e27
205316topiramate 15 MG Oral CapsuleSCDe4886adf-199d-4b19-a4ef-75f8f94cb54e27
205315topiramate 25 MG Oral CapsuleSCDe4886adf-199d-4b19-a4ef-75f8f94cb54e27
252413topiramate 50 MG Oral CapsuleSCDe4886adf-199d-4b19-a4ef-75f8f94cb54e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68382-498-146838204981460 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-498-14) 2024-10-24NoNoHistorical