Spritam
- Product NDC
- 43485-101
- 11-digit product format
- 434850101
- Labeler code
- 43485
- Product ID
- 43485-101_890ef534-7363-4f2b-b125-8f62e2eb26d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Aprecia Pharmaceuticals, LLC
- Application
- NDA207958
- Marketing category
- NDA
- Marketing start
- 2016-02-05
- Substance
- LEVETIRACETAM
- Active strength
- 250 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N207958-001 | SPRITAM | LEVETIRACETAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | |
| N207958-002 | SPRITAM | LEVETIRACETAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | |
| N207958-003 | SPRITAM | LEVETIRACETAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | |
| N207958-004 | SPRITAM | LEVETIRACETAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N207958-001 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | |
| N207958-001 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2017-07-25 |
| N207958-001 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | |
| N207958-001 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | |
| N207958-001 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | |
| N207958-002 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | |
| N207958-002 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 |
| N207958-002 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | |
| N207958-002 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | |
| N207958-002 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | |
| N207958-003 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | |
| N207958-003 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 |
| N207958-003 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | |
| N207958-003 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | |
| N207958-003 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | |
| N207958-004 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | |
| N207958-004 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 |
| N207958-004 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | |
| N207958-004 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | |
| N207958-004 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 |
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 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207958-001 | SPRITAM | 250MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207958-002 | SPRITAM | 500MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207958-003 | SPRITAM | 750MG | TABLET, FOR SUSPENSION / ORAL | RLD | 2015-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207958-004 | SPRITAM | 1GM | TABLET, FOR SUSPENSION / ORAL | RLD, RS | 2015-07-31 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N207958-001 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-001 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2017-07-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-001 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-001 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-001 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-002 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-002 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-002 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-002 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-002 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-003 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-003 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-003 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-003 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-003 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-004 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-004 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-004 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-004 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207958-004 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-001 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-001 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2017-07-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-001 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-001 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-001 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-002 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-002 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-002 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-002 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-002 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-003 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-003 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-003 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-003 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-003 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-004 | 11160786 | 2034-03-14 | Drug product | 2021-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-004 | 9339489 | 2034-03-14 | U-1850 | Drug product | 2016-06-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-004 | 9669009 | 2034-03-14 | U-1850 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-004 | 9669009 | 2034-03-14 | U-2021 | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207958-004 | 9669009 | 2034-03-14 | U-2022 | 2017-06-28 | 31067a03dcf5… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Spritam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVETIRACETAM | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44YRR34555 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1736037 | Internal RxNorm lookup |
| 1736044 | Internal RxNorm lookup |
| 1736045 | Internal RxNorm lookup |
| 1736047 | Internal RxNorm lookup |
| 1736048 | Internal RxNorm lookup |
| 1736050 | Internal RxNorm lookup |
| 1736051 | Internal RxNorm lookup |
| 1736053 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| be651c31-383f-11e4-916c-0800200c9a66 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 76e81f18-c6b9-f226-530a-a6296d5cd5f4 | Product name | 6 | 20251106 |
| 087c9486-f4a9-a565-c6fb-d6fa49f4572a | Product name | 6 | 20230317 |
| 525a8d4d-1988-fc3f-e292-27fd384de4f0 | Product name | 8 | 20230104 |
| 32b651f8-caa7-6882-11c7-54c4ad21796b | Product name | 8 | 20201216 |
| ce453ca5-90cf-41ed-9de4-de519f70a0f2 | Product name | 2 | 20160303 |
| 66666eb8-1fa6-4a60-bae9-e564e73b4cd5 | Product name | 1 | 20150728 |
| eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477 | Product name | 1 | 20150410 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43485-101-01 | Spritam | 1 in 1 BLISTER PACK | TABLET, FOR SUSPENSION | 1 | 29 | |
| 43485-101-03 | Spritam | 6 in 1 CARTON | TABLET, FOR SUSPENSION | 6 | 29 | |
| 43485-101-60 | Spritam | 60 in 1 CARTON | TABLET, FOR SUSPENSION | 60 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43485-101-01 | EA - Each | 43485-101 | 896fe2d2-0b5d-4f2e-94f5-b1c1c5505b36 | 1 | 2016-03-04 |
| 43485-101-60 | EA - Each | 43485-101 | c7fa9dc8-dccc-453a-976c-ea00b52ea901 | 1 | 2016-03-04 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Spritam | LEVETIRACETAM | Aprecia Pharmaceuticals, LLC | be651c31-383f-11e4-916c-0800200c9a66 | 2025-10-13 | Warnings, Adverse reactions | 207958 NDA207958 43485-101 |
| Levetiracetam | LEVETIRACETAM | Prasco Laboratories | dd175fa3-1d7a-4542-affd-988ac5bba1db | 2025-07-01 | Warnings, Adverse reactions | 207958 NDA207958 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1736037 | levETIRAcetam 1000 MG Tablet for Oral Suspension | PSN | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736045 | levETIRAcetam 250 MG Tablet for Oral Suspension | PSN | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736048 | levETIRAcetam 500 MG Tablet for Oral Suspension | PSN | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736051 | levETIRAcetam 750 MG Tablet for Oral Suspension | PSN | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736044 | Spritam 1000 MG Tablet for Oral Suspension | PSN | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736047 | Spritam 250 MG Tablet for Oral Suspension | PSN | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736050 | Spritam 500 MG Tablet for Oral Suspension | PSN | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736053 | Spritam 750 MG Tablet for Oral Suspension | PSN | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736044 | levetiracetam 1000 MG Tablet for Oral Suspension [Spritam] | SBD | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736047 | levetiracetam 250 MG Tablet for Oral Suspension [Spritam] | SBD | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736050 | levetiracetam 500 MG Tablet for Oral Suspension [Spritam] | SBD | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736053 | levetiracetam 750 MG Tablet for Oral Suspension [Spritam] | SBD | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736037 | levetiracetam 1000 MG Tablet for Oral Suspension | SCD | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736045 | levetiracetam 250 MG Tablet for Oral Suspension | SCD | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736048 | levetiracetam 500 MG Tablet for Oral Suspension | SCD | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736051 | levetiracetam 750 MG Tablet for Oral Suspension | SCD | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736037 | levetiracetam 1000 MG Tablet for Oral Suspension | SY | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736045 | levetiracetam 250 MG Tablet for Oral Suspension | SY | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736048 | levetiracetam 500 MG Tablet for Oral Suspension | SY | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736051 | levetiracetam 750 MG Tablet for Oral Suspension | SY | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736044 | Spritam 1000 MG Tablet for Oral Suspension | SY | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736047 | Spritam 250 MG Tablet for Oral Suspension | SY | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736050 | Spritam 500 MG Tablet for Oral Suspension | SY | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
| 1736053 | Spritam 750 MG Tablet for Oral Suspension | SY | be651c31-383f-11e4-916c-0800200c9a66 | 29 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43485-101-01 | 43485010101 | 1 in 1 BLISTER PACK | Historical | |||||
| 43485-101-03 | 43485010103 | 6 BLISTER PACK in 1 CARTON (43485-101-03) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01) | 6 blister pack | 2026-01-31 | No | No | Current | |
| 43485-101-60 | 43485010160 | 60 BLISTER PACK in 1 CARTON (43485-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01) | 60 blister pack | 2016-02-05 | 0000-00-00 | No | No | Current |