Topiramate
- Product NDC
- 27808-329
- 11-digit product format
- 278080329
- Labeler code
- 27808
- Product ID
- 27808-329_82389c83-d085-4c1a-ab9c-480b4f9c6058
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA218695
- Marketing category
- ANDA
- Marketing start
- 2026-10-01
- Substance
- TOPIRAMATE
- Active strength
- 200 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218695-001 | TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | |
| A218695-002 | TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | |
| A218695-003 | TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | |
| A218695-004 | TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | |
| A218695-005 | TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218695-001 | AB2 |
| A218695-002 | AB2 |
| A218695-003 | AB2 |
| A218695-004 | AB2 |
| A218695-005 | AB2 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218695-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218695-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218695-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218695-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218695-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218695-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218695-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218695-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218695-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218695-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-004 | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-005 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2024-12-03 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218695-001 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218695-002 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218695-003 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218695-004 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218695-005 | AB2 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218695-001 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218695-002 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218695-003 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218695-004 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218695-005 | AB2 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-003 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-004 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218695-005 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218695-005 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-004 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218695-005 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-003 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-004 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218695-005 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-004 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218695-005 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-002 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-003 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-004 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218695-005 | AB2 | 1 | 03ed91905a0d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOPIRAMATE | 200 mg/1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 27808-329-01 | 27808032901 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27808-329-01) | 2026-10-01 | No | No | Current |