TOPIRAMATE
- Product NDC
- 61919-825
- 11-digit product format
- 619190825
- Labeler code
- 61919
- Product ID
- 61919-825_9cad467c-4922-723b-e053-2a95a90ab82b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA079153
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 61919-825 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 61919-825 | 61919-825-30 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 61919-825 | 61919-825-60 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 61919-825 | 61919-825-90 | I | Inactivated by FDA | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61919-825-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61919-825-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61919-825-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61919-825-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61919-825-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61919-825-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61919-825-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61919-825-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61919-825-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61919-825-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61919-825-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61919-825-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61919-825-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61919-825-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61919-825-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61919-825-90 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61919-825-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61919-825-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61919-825-90 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61919-825-60 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61919-825-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61919-825-90 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61919-825-60 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61919-825-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61919-825-90 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61919-825-60 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61919-825-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61919-825-90 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61919-825-60 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61919-825-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61919-825-90 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61919-825-60 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61919-825-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61919-825-90 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61919-825-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61919-825-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 61919-825-90 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 61919-825-60 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 61919-825-30 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 61919-825-90 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 61919-825-60 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 61919-825-30 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 61919-825-90 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 61919-825-60 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 61919-825-30 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079153-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | ||
| A079153-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | ||
| A079153-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | ||
| A079153-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079153-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079153-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079153-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079153-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A079153-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079153-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079153-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079153-004 | AB | 1 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | A079153-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A079153-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A079153-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A079153-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A079153-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A079153-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A079153-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A079153-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A079153-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079153-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079153-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079153-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A079153-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079153-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079153-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079153-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A079153-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079153-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079153-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079153-004 | AB | 1 | ea99ee380514… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-825-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-f31b-0266-e053-dadaa90a7c1a | TOPIRAMATE |
| 61919-825-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-f31b-0266-e053-dadaa90a7c1a | TOPIRAMATE |
| 61919-825-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-f31b-0266-e053-dadaa90a7c1a | TOPIRAMATE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-825-30 | TOPIRAMATE | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 61919-825-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 61919-825-90 | TOPIRAMATE | 90 in 1 BOTTLE | TABLET | 90 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-825-30 | EA - Each | 61919-825 | f3fa7ab1-6051-4aac-b6dd-a3701d260930 | 1 | 2015-12-02 |
| 61919-825-60 | EA - Each | 61919-825 | 7244437a-9d5a-4e1d-b7c6-28e5b5b8664e | 1 | 2014-07-02 |
| 61919-825-90 | EA - Each | 61919-825 | 210a4867-5f7a-4eca-8790-fdc315f48f5a | 1 | 2015-12-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET [DIRECT RX] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET [DIRECT RX] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 151226 | topiramate 50 MG Oral Tablet | PSN | 44db00eb-4ec7-47f9-82c9-4bb767f5ba3f | 5 |
| 151226 | topiramate 50 MG Oral Tablet | SCD | 44db00eb-4ec7-47f9-82c9-4bb767f5ba3f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-825-30 | 61919082530 | 30 TABLET in 1 BOTTLE (61919-825-30) | 30 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-825-60 | 61919082560 | 60 TABLET in 1 BOTTLE (61919-825-60) | 60 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-825-90 | 61919082590 | 90 TABLET in 1 BOTTLE (61919-825-90) | 90 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |