TOPIRAMATE
- Product NDC
- 13668-032
- 11-digit product format
- 136680032
- Labeler code
- 13668
- Product ID
- 13668-032_16ea5453-3213-4fef-9918-92f5c7179798
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA079153
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET [STAT RX USA LLC] | 3 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-032-01 | 13668003201 | 100 TABLET in 1 BOTTLE (13668-032-01) | 100 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-032-05 | 13668003205 | 500 TABLET in 1 BOTTLE (13668-032-05) | 500 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-032-30 | 13668003230 | 30 TABLET in 1 BOTTLE (13668-032-30) | 30 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-032-42 | 13668003242 | 6000 TABLET in 1 BOTTLE (13668-032-42) | 6000 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-032-60 | 13668003260 | 60 TABLET in 1 BOTTLE (13668-032-60) | 60 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |
| 13668-032-74 | 13668003274 | 100 TABLET in 1 DOSE PACK (13668-032-74) | 100 tablet | 2009-03-27 | 0000-00-00 | No | No | Current |