Topiramate
- Product NDC
- 70771-1657
- 11-digit product format
- 707711657
- Labeler code
- 70771
- Product ID
- 70771-1657_432dc54b-f28b-48c9-b417-2fbae070f41b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA208949
- Marketing category
- ANDA
- Marketing start
- 2023-01-17
- 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
- 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 |
|---|---|
| TOPIRAMATE | 50 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0H73WJJ391 |
| Rxcui | 1494769, 1812419, 1812421, 1812425, 1812427 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e5b1b0ba-27f8-4d5d-8943-8aed080fdedc | Product name | 4 | 20260306 |
| 6c26dd6d-01b5-4a80-b096-b3a6f7ca6077 | Product name | 2 | 20250623 |
| cb966f54-bbf0-40fb-b581-80c6648d510c | Product name | 4 | 20250623 |
| 6e2fb0d7-40d7-e97c-1375-fa022ff20193 | Product name | 4 | 20250305 |
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1657-3 | Topiramate | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 3 | |
| 70771-1657-9 | Topiramate | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70771-1657 | TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, 2 package rows | 20230928_57b5d67b-b29b-4c18-a53d-51d5374f3be3.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1812427 | topiramate 100 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1494769 | topiramate 150 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812419 | topiramate 200 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812421 | topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812425 | topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule | PSN | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812427 | Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule | SCD | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1494769 | Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule | SCD | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812419 | Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule | SCD | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812421 | Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule | SCD | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812425 | Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule | SCD | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812427 | topiramate 100 MG Sprinkle 24 HR Extended Release Oral Capsule | SY | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1494769 | topiramate 150 MG Sprinkle 24 HR Extended Release Oral Capsule | SY | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812419 | topiramate 200 MG Sprinkle 24 HR Extended Release Oral Capsule | SY | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812421 | topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule | SY | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
| 1812425 | topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule | SY | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 70771-1657-3 | 70771165703 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1657-3) | 2023-01-17 | No | No | Historical |
| 70771-1657-9 | 70771165709 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1657-9) | 2023-01-17 | No | No | Historical |