FDA.reportPublic FDA data

topiramate

Product NDC
29300-116
11-digit product format
293000116
Labeler code
29300
Product ID
29300-116_961973db-b7ab-40fa-ad75-4163738def9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA090162
Marketing category
ANDA
Marketing start
2013-07-01
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
Rxcui151226, 199888, 199889, 199890

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
29300-116-01topiramate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
29300-116-05topiramate500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50020
29300-116-10topiramate1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100020
29300-116-16topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-116-05EA - Each29300-116a40faabf-562e-4a54-b242-8cb613522b1412016-02-04
29300-116-10EA - Each29300-11698bd314e-5bad-4dcd-83e6-0eafb141b19a12015-08-04
29300-116-16EA - Each29300-11627dc2a38-520b-4647-a42f-d0e0d3538e8f12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WETOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-116TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]19Current NDC, Legacy NDC, 4 package rows20250416_6ee00e82-799d-445e-b658-a9712c49a28e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNbf732c34-9078-496a-8093-f68594e76fcb101
151226topiramate 50 MG Oral TabletSCDbf732c34-9078-496a-8093-f68594e76fcb101
199889topiramate 100 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199888topiramate 25 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
151226topiramate 50 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199889topiramate 100 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199888topiramate 25 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
151226topiramate 50 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199889topiramate 100 MG Oral TabletPSN6ee00e82-799d-445e-b658-a9712c49a28e20
199890topiramate 200 MG Oral TabletPSN6ee00e82-799d-445e-b658-a9712c49a28e20
199888topiramate 25 MG Oral TabletPSN6ee00e82-799d-445e-b658-a9712c49a28e20
151226topiramate 50 MG Oral TabletPSN6ee00e82-799d-445e-b658-a9712c49a28e20
199889topiramate 100 MG Oral TabletSCD6ee00e82-799d-445e-b658-a9712c49a28e20
199890topiramate 200 MG Oral TabletSCD6ee00e82-799d-445e-b658-a9712c49a28e20
199888topiramate 25 MG Oral TabletSCD6ee00e82-799d-445e-b658-a9712c49a28e20
151226topiramate 50 MG Oral TabletSCD6ee00e82-799d-445e-b658-a9712c49a28e20
199888topiramate 25 MG Oral TabletPSNf66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b5
151226topiramate 50 MG Oral TabletPSNf66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b5
151226topiramate 50 MG Oral TabletPSN073d075d-d019-4834-b55d-9b95879149755
199888topiramate 25 MG Oral TabletSCDf66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b5
151226topiramate 50 MG Oral TabletSCD073d075d-d019-4834-b55d-9b95879149755
151226topiramate 50 MG Oral TabletSCDf66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b5
151226topiramate 50 MG Oral TabletPSN816566bf-b909-606f-e053-2a91aa0ab8c94
151226topiramate 50 MG Oral TabletPSNf16065c0-9949-9ac4-e053-2995a90a3b024
151226topiramate 50 MG Oral TabletSCD816566bf-b909-606f-e053-2a91aa0ab8c94
151226topiramate 50 MG Oral TabletSCDf16065c0-9949-9ac4-e053-2995a90a3b024
151226topiramate 50 MG Oral TabletPSNcc918c0d-2b1e-4fa0-b4d3-9dbc287180183
151226topiramate 50 MG Oral TabletSCDcc918c0d-2b1e-4fa0-b4d3-9dbc287180183
151227Topamax 50 MG Oral TabletPSN33c0fc7a-aa48-34ae-e054-00144ff8d46c1
151226topiramate 50 MG Oral TabletPSN33c0fc7a-aa48-34ae-e054-00144ff8d46c1
151226topiramate 50 MG Oral TabletPSN30ca2fce-4e4c-439e-e063-6294a90af0761
151226topiramate 50 MG Oral TabletPSNc6918801-f22c-4ba4-a396-da484d4334ca1
151226topiramate 50 MG Oral TabletPSN288d6b40-8c87-4f16-85a7-86166b5ac77f1
151226topiramate 50 MG Oral TabletPSN50b10a3d-883c-8891-e063-6394a90a86a11
151227topiramate 50 MG Oral Tablet [Topamax]SBD33c0fc7a-aa48-34ae-e054-00144ff8d46c1
151226topiramate 50 MG Oral TabletSCD30ca2fce-4e4c-439e-e063-6294a90af0761
151226topiramate 50 MG Oral TabletSCDc6918801-f22c-4ba4-a396-da484d4334ca1
151226topiramate 50 MG Oral TabletSCD33c0fc7a-aa48-34ae-e054-00144ff8d46c1
151226topiramate 50 MG Oral TabletSCD288d6b40-8c87-4f16-85a7-86166b5ac77f1
151226topiramate 50 MG Oral TabletSCD50b10a3d-883c-8891-e063-6394a90a86a11
151227Topamax 50 MG Oral TabletSY33c0fc7a-aa48-34ae-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-116-0129300011601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-01) 2013-07-010000-00-00NoNoCurrent
29300-116-0529300011605500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-05) 2013-07-010000-00-00NoNoCurrent
29300-116-10293000116101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-10) 2013-07-010000-00-00NoNoCurrent
29300-116-162930001161660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-16) 2013-07-010000-00-00NoNoCurrent