TOPIRAMATE
- Product NDC
- 31722-181
- 11-digit product format
- 317220181
- Labeler code
- 31722
- Product ID
- 31722-181_62911647-4208-47b3-a9af-67f026411019
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA215414
- Marketing category
- ANDA
- Marketing start
- 2021-09-22
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOPIRAMATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226, 199888, 199889, 199890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-181-05 | TOPIRAMATE | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 31722-181-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-181 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230928_cefbc5f4-ef5f-4732-ab96-a69a183f0b6b.zip |
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 |
|---|
| 31722-181-05 | 31722018105 | 500 TABLET in 1 BOTTLE (31722-181-05) | 500 tablet | 2021-09-22 | 0000-00-00 | No | No | Current |
| 31722-181-60 | 31722018160 | 60 TABLET in 1 BOTTLE (31722-181-60) | 60 tablet | 2021-09-22 | 0000-00-00 | No | No | Current |