Levetiracetam

Product NDC
68083-153
11-digit product format
680830153
Labeler code
68083
Product ID
68083-153_446e0964-1e66-48ae-8065-da9c88662828
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA206880
Marketing category
ANDA
Marketing start
2017-11-07
Substance
LEVETIRACETAM
Active strength
10 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206880-001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25
A206880-002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25
A206880-003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206880-001AP
A206880-002AP
A206880-003AP

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 UTC2026-02A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-258072bd15b7f6…

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 UTC2026-02A206880-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206880-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206880-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206880-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206880-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206880-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206880-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206880-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206880-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206880-001AP18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44YRR34555Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1193358Internal RxNorm lookup
1193360Internal RxNorm lookup
1193362Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa883d9c-c6cd-44ab-a1de-058985e4f97fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-153-01Levetiracetam100 mL in 1 BAGINJECTION10012
68083-153-10Levetiracetam10 in 1 CARTONINJECTION1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-153LEVETIRACETAM INJECTION [GLAND PHARMA LIMITED]12Current NDC, Legacy NDC, 2 package rows20240418_aa883d9c-c6cd-44ab-a1de-058985e4f97f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levetiracetamLEVETIRACETAMSagent Pharmaceuticalsd2de9565-0c0b-4957-bafa-1a286103709e2024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206880
application number: ANDA206880
LevetiracetamLEVETIRACETAMGland Pharma Limitedaa883d9c-c6cd-44ab-a1de-058985e4f97f2024-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206880
application number: ANDA206880
ndc (product): 68083-153
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Incbe8ec971-c4f1-3e53-77e1-8337d9d506eb2021-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206880
application number: ANDA206880
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Inc0a9234b7-46b1-8e6c-a992-90f86cfb6e002021-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206880
application number: ANDA206880

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193358levETIRAcetam 1000 MG in 100 ML InjectionPSNaa883d9c-c6cd-44ab-a1de-058985e4f97f12
1193360levETIRAcetam 1500 MG in 100 ML InjectionPSNaa883d9c-c6cd-44ab-a1de-058985e4f97f12
1193362levETIRAcetam 500 MG in 100 ML InjectionPSNaa883d9c-c6cd-44ab-a1de-058985e4f97f12
1193358100 ML levetiracetam 10 MG/ML InjectionSCDaa883d9c-c6cd-44ab-a1de-058985e4f97f12
1193360100 ML levetiracetam 15 MG/ML InjectionSCDaa883d9c-c6cd-44ab-a1de-058985e4f97f12
1193362100 ML levetiracetam 5 MG/ML InjectionSCDaa883d9c-c6cd-44ab-a1de-058985e4f97f12
1193358levetiracetam 1000 MG per 100 ML InjectionSYaa883d9c-c6cd-44ab-a1de-058985e4f97f12
1193360levetiracetam 1500 MG per 100 ML InjectionSYaa883d9c-c6cd-44ab-a1de-058985e4f97f12
1193362levetiracetam 500 MG per 100 ML InjectionSYaa883d9c-c6cd-44ab-a1de-058985e4f97f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-153-0168083015301100 mL in 1 BAG100 mlHistorical
68083-153-106808301531010 BAG in 1 CARTON (68083-153-10) / 100 mL in 1 BAG (68083-153-01) 10 bag2017-11-070000-00-00NoNoCurrent