FDA.reportPublic FDA data

Application 078154

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMTABLET;ORAL250MGNoNo
002LEVETIRACETAMLEVETIRACETAMTABLET;ORAL500MGNoNo
003LEVETIRACETAMLEVETIRACETAMTABLET;ORAL750MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078154-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-01-15
A078154-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-01-15
A078154-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078154-001AB
A078154-002AB
A078154-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078154-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-158072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078154-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078154-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078154-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078154-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078154-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078154-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078154-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078154-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078154-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078154-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078154-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078154-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078154-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078154-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078154-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078154-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078154-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078154-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078154-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078154-001AB18072bd15b7f6…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.a1b28234-1f7c-40bf-80a7-6cc98b3839fe2026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.1c26c0ad-9d37-45c5-9091-849509f4fc012026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
ndc (product): 70518-1108
LevetiracetamLEVETIRACETAMBryant Ranch Prepack90e01877-abcb-4697-a7ed-9afe5ee770502026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.c4b2da6a-ed50-4a54-90bd-32f76b1787362026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
ndc (product): 43063-617
LevetiracetamLEVETIRACETAMLupin Pharmaceuticals, Inc.df661166-325d-4071-9bc1-f7bf992996d22026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
ndc (product): 68180-114
ndc (product): 68180-113
ndc (product): 68180-112
LevetiracetamLEVETIRACETAMBryant Ranch Prepack24f815ef-58e6-42b9-8137-adcd6c382aa62026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
ndc (product): 63629-4137
LevetiracetamLEVETIRACETAMBryant Ranch Prepack9e3171c9-70e2-4725-8aca-c7f83773940d2026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
ndc (product): 63629-4675
LevetiracetamLEVETIRACETAMPreferred Pharmaceuticals, Inc.e31c6830-4647-4481-b4f1-494a52c48b1b2025-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
ndc (product): 68788-8254
LevetiracetamLEVETIRACETAMProficient Rx LP6bdbc193-d86b-4bd5-8e88-4ea964d2cdde2024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078154
application number: ANDA078154
ndc (product): 63187-360

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 92 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-644LevetiracetamLevetiracetamAidarex Pharmaceuticals LLCANDACurrent
33261-645LevetiracetamLevetiracetamAidarex Pharmaceuticals LLCANDACurrent
33261-646LevetiracetamLevetiracetamAidarex Pharmaceuticals LLCANDACurrent
35356-533LevetiracetamLevetiracetamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-621LevetiracetamLevetiracetamLake Eire Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
42254-310LevetiracetamLevetiracetamRebel Distributors CorpANDACurrent
43063-617LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-617LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-617LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-617LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-617LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2456LevetiracetamLevetiracetamA-S Medication SolutionsANDACurrent
50090-2456LevetiracetamLevetiracetamA-S Medication SolutionsANDACurrent
50090-2456LevetiracetamLevetiracetamA-S Medication SolutionsANDACurrent
50436-5604LevetiracetamLevetiracetamUnit Dose ServicesANDACurrent
50436-5605LevetiracetamLevetiracetamUnit Dose ServicesANDACurrent
50436-5606LevetiracetamLevetiracetamUnit Dose ServicesANDACurrent
57297-112LevetiracetamLevetiracetamLUPIN LIMITEDANDACurrent
57297-113LevetiracetamLevetiracetamLUPIN LIMITEDANDACurrent
57297-114LevetiracetamLevetiracetamLUPIN LIMITEDANDACurrent
58118-1112LevetiracetamLevetiracetamClinical Solutions Wholesale, LLCANDACurrent
58118-1112LevetiracetamLevetiracetamClinical Solutions Wholesale, LLCANDACurrent
58118-1112LevetiracetamLevetiracetamClinical Solutions Wholesale, LLCANDACurrent
58118-1112LevetiracetamLevetiracetamClinical Solutions Wholesale, LLCANDACurrent
61919-320LEVETIRACETAMLEVETIRACETAMDIRECT RXANDACurrent
61919-685LEVETIRACETAMLEVETIRACETAMDIRECT RXANDACurrent
61919-685LEVETIRACETAMLEVETIRACETAMDIRECT RXANDACurrent
61919-685LEVETIRACETAMLEVETIRACETAMDIRECT RXANDACurrent
63187-360LevetiracetamLevetiracetamProficient Rx LPANDACurrent
63187-360LevetiracetamLevetiracetamProficient Rx LPANDACurrent
63629-4137LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-4137LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-4137LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-4137LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-4675LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-4675LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-4675LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-5038LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
64725-1130LevetiracetamLevetiracetamTYA PharmaceuticalsANDACurrent
67046-420LevetiracetamLevetiracetamContract Pharmacy Services-PAANDACurrent
67296-1636LevetiracetamLevetiracetamRedPharm Drug, Inc.ANDACurrent
67296-1636LevetiracetamLevetiracetamRedPharm Drug, Inc.ANDACurrent
68001-116LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-116LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-117LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-117LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-118LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-118LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68180-112LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-112LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-112LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-112LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-112LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-112LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-112LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-113LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-113LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-113LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-113LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-113LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-113LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-113LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-114LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-114LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-114LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-114LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-114LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-114LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-114LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68788-6838LevetiracetamLevetiracetamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7190LevetiracetamLevetiracetamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7190LevetiracetamLevetiracetamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8254LevetiracetamLevetiracetamPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1108LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1108LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1108LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1348LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1348LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1482LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1482LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent