Home NDC 50474-597 Keppra
Product NDC 50474-597
11-digit product format 504740597
Labeler code 50474
Product ID 50474-597_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 1000 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table 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# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table 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.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table 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# Normalized TE history page 1 of 5 · 164 observed states.
Observed Orange Book patent history# Patent history page 1 of 9 · 328 observed states.
Captured, Edition, Application-product table 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 table Ingredient Strength LEVETIRACETAM 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 44YRR34555 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table 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# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50474-597-66 Keppra 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded levetiracetam ACTIVE INGREDIENT 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 levetiracetam ACTIVE MOIETY 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 aluminum oxide INACTIVE INGREDIENT LMI26O6933 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 ammonium glycyrrhizate INACTIVE INGREDIENT 3VRD35U26C KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 FD&C blue no. 2 INACTIVE INGREDIENT L06K8R7DQK KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 glycerin INACTIVE INGREDIENT PDC6A3C0OX KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 indigotindisulfonate sodium INACTIVE INGREDIENT D3741U8K7L KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 methylparaben INACTIVE INGREDIENT A2I8C7HI9T KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 polyethylene glycol 6000 INACTIVE INGREDIENT 30IQX730WE KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 talc INACTIVE INGREDIENT 7SEV7J4R1U KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 water INACTIVE INGREDIENT 059QF0KO0R KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 16 levetiracetam ACTIVE INGREDIENT 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 levetiracetam ACTIVE MOIETY 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 aluminum oxide INACTIVE INGREDIENT LMI26O6933 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 polyethylene glycol 6000 INACTIVE INGREDIENT 30IQX730WE KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50474-597 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.] 32 Current NDC, Legacy NDC, 1 package rows 20240430_3ca9df05-a506-4ec8-a4fe-320f1219ab21.zip
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50474-597-66 50474059766 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-597-66) 2000-04-24 0000-00-00 No No Current