FDA.reportPublic FDA data

levocarnitine

Product NDC
73043-034
11-digit product format
730430034
Labeler code
73043
Product ID
73043-034_d1a8933e-ee3b-4183-a9bd-8c22eab71dfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocarnitine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Devatis Inc.
Application
ANDA217430
Marketing category
ANDA
Marketing start
2025-11-01
Substance
LEVOCARNITINE
Active strength
1 g/5mL
Pharmacologic classes
Carnitine Analog [EPC], Carnitine [CS]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217430-001LEVOCARNITINELEVOCARNITINE200MG/MLINJECTABLE / INJECTIONAP2025-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217430-001AP

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217430-001LEVOCARNITINE200MG/MLINJECTABLE / INJECTIONAP2025-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217430-001LEVOCARNITINE200MG/MLINJECTABLE / INJECTIONAP2025-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217430-001LEVOCARNITINE200MG/MLINJECTABLE / INJECTIONAP2025-06-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217430-001LEVOCARNITINE200MG/MLINJECTABLE / INJECTIONAP2025-06-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217430-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217430-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217430-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217430-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCARNITINE1 g/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0G389FZZ9MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1791371Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
79b6182c-ead5-4fdd-bafa-1afbc7a77906Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73043-034-05levocarnitine5 mL in 1 VIALINJECTION, SOLUTION51
73043-034-05levocarnitine5 in 1 CARTONINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73043-034-05ML - Milliliter73043-0340090a01e-2a9e-4f2b-97e5-145cc925a5a412026-02-05

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levocarnitineLEVOCARNITINEDevatis Inc.79b6182c-ead5-4fdd-bafa-1afbc7a779062025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217430
application number: ANDA217430
ndc (product): 73043-034

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791371levOCARNitine 1 GM in 5 ML InjectionPSN79b6182c-ead5-4fdd-bafa-1afbc7a779061
17913715 ML levocarnitine 200 MG/ML InjectionSCD79b6182c-ead5-4fdd-bafa-1afbc7a779061
1791371levocarnitine 1 GM per 5 ML InjectionSY79b6182c-ead5-4fdd-bafa-1afbc7a779061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-034-05730430034055 VIAL in 1 CARTON (73043-034-05) / 5 mL in 1 VIAL5 vial2025-11-01NoNoCurrent