Keppra
- Product NDC
- 50474-595
- 11-digit product format
- 504740595
- Labeler code
- 50474
- Product ID
- 50474-595_4974b225-87ca-610e-e063-6294a90ad20a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- UCB, Inc.
- Application
- NDA021035
- Marketing category
- NDA
- Marketing start
- 2000-04-24
- Substance
- LEVETIRACETAM
- Active strength
- 500 mg/1
- Pharmacologic classes
- 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 |
|---|---|---|---|---|---|---|---|
| N021035-001 | KEPPRA | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 |
| N021035-002 | KEPPRA | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 |
| N021035-003 | KEPPRA | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 |
| N021035-004 | KEPPRA | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021035-001 | AB |
| N021035-002 | AB |
| N021035-003 | AB |
| N021035-004 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021035-001 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | |
| N021035-001 | 8802142*PED | 2031-12-07 | Pediatric extension | ||
| N021035-002 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | |
| N021035-002 | 8802142*PED | 2031-12-07 | Pediatric extension | ||
| N021035-003 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | |
| N021035-003 | 8802142*PED | 2031-12-07 | Pediatric extension | ||
| N021035-004 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | |
| N021035-004 | 8802142*PED | 2031-12-07 | Pediatric extension |
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 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021035-001 | KEPPRA | 250MG | TABLET / ORAL | AB | RLD | 1999-11-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021035-002 | KEPPRA | 500MG | TABLET / ORAL | AB | RLD | 1999-11-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021035-003 | KEPPRA | 750MG | TABLET / ORAL | AB | RLD | 1999-11-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021035-004 | KEPPRA | 1GM | TABLET / ORAL | AB | RLD, RS | 2006-01-06 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021035-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021035-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021035-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021035-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021035-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021035-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021035-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021035-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021035-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021035-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021035-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021035-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021035-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021035-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021035-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021035-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021035-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021035-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021035-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021035-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021035-004 | AB | 1 | 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 | N021035-001 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-001 | 8802142*PED | 2031-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021035-002 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-002 | 8802142*PED | 2031-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021035-003 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-003 | 8802142*PED | 2031-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021035-004 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021035-004 | 8802142*PED | 2031-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-001 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-001 | 8802142*PED | 2031-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-002 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-002 | 8802142*PED | 2031-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-003 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-003 | 8802142*PED | 2031-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-004 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021035-004 | 8802142*PED | 2031-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021035-001 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-001 | 8802142*PED | 2031-12-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021035-002 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-002 | 8802142*PED | 2031-12-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021035-003 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-003 | 8802142*PED | 2031-12-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021035-004 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021035-004 | 8802142*PED | 2031-12-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-001 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-001 | 8802142*PED | 2031-12-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-002 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-002 | 8802142*PED | 2031-12-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-003 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-003 | 8802142*PED | 2031-12-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-004 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021035-004 | 8802142*PED | 2031-12-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-001 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-001 | 8802142*PED | 2031-12-07 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-002 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-002 | 8802142*PED | 2031-12-07 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-003 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-003 | 8802142*PED | 2031-12-07 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-004 | 8802142 | 2031-06-07 | Drug product | 2014-09-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021035-004 | 8802142*PED | 2031-12-07 | Pediatric extension | b8a1b40f171c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Keppra
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVETIRACETAM | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44YRR34555 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 261335 | Internal RxNorm lookup |
| 261336 | Internal RxNorm lookup |
| 284391 | Internal RxNorm lookup |
| 311288 | Internal RxNorm lookup |
| 311289 | Internal RxNorm lookup |
| 311290 | Internal RxNorm lookup |
| 387003 | Internal RxNorm lookup |
| 403884 | Internal RxNorm lookup |
| 404595 | Internal RxNorm lookup |
| 630807 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ca9df05-a506-4ec8-a4fe-320f1219ab21 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 76e81f18-c6b9-f226-530a-a6296d5cd5f4 | Product name | 6 | 20251106 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 087c9486-f4a9-a565-c6fb-d6fa49f4572a | Product name | 6 | 20230317 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
| 525a8d4d-1988-fc3f-e292-27fd384de4f0 | Product name | 8 | 20230104 |
| 32b651f8-caa7-6882-11c7-54c4ad21796b | Product name | 8 | 20201216 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| 50474-595-40 | Keppra | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | 36 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50474-595-40 | EA - Each | 50474-595 | ea4c1ad5-3d93-408c-a757-362808ffa95f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Keppra | LEVETIRACETAM | UCB, Inc. | 3ca9df05-a506-4ec8-a4fe-320f1219ab21 | 2026-01-28 | Warnings, Adverse reactions | 021035 NDA021035 50474-595 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50474-595-40 | 50474059540 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40) | 2000-04-24 | 0000-00-00 | No | No | Current |