FDA.reportPublic FDA data

Levorphanol Tartrate

Product NDC
0406-2224
11-digit product format
004062224
Labeler code
0406
Product ID
0406-2224_72cc6b5a-55a3-405c-bf1d-c8810077aa21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levorphanol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA212024
Marketing category
ANDA
Marketing start
2019-12-13
Substance
LEVORPHANOL TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212024-001LEVORPHANOL TARTRATELEVORPHANOL TARTRATE2MGTABLET / ORALAB2019-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212024-001AB

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
2026-08-01 22:54:322026-06A212024-001LEVORPHANOL TARTRATE2MGTABLET / ORALAB2019-12-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212024-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levorphanol TartrateLEVORPHANOL TARTRATESpecGx LLC759c7040-0be0-4d17-be97-e467e423eaa82026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212024
application number: ANDA212024
ndc (product): 0406-2224

Additional Listing Data#

Finished product
Yes
Brand name base
Levorphanol Tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVORPHANOL TARTRATE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04WQU6T9QIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197873Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
759c7040-0be0-4d17-be97-e467e423eaa8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
34ec43f3-43ad-c434-04a6-9d47021af3a1Product name520220118

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0406-2224-012020-10-07C16284748780-1ab0e2407-273b-f274-e053-dbdaa90a6471Levorphanol Tartrate Tablets USP, CII
0406-2224-012020-10-07C16284748780-1ab0e2407-273b-f274-e053-dbdaa90a6471Levorphanol Tartrate Tablets USP, CII
0406-2224-012020-09-27C16284748780-1ab0e2407-273b-f274-e053-dbdaa90a6471Levorphanol Tartrate Tablets USP, CII
0406-2224-012020-09-27C16284748780-1ab0e2407-273b-f274-e053-dbdaa90a6471Levorphanol Tartrate Tablets USP, CII
0406-2224-012020-09-25C16284748780-1ab0e2407-273b-f274-e053-dbdaa90a6471Levorphanol Tartrate Tablets USP, CII
0406-2224-012020-09-25C16284748780-1ab0e2407-273b-f274-e053-dbdaa90a6471Levorphanol Tartrate Tablets USP, CII
0406-2224-012020-07-22C16284748780-1ab0e2407-273b-f274-e053-dbdaa90a6471Levorphanol Tartrate Tablets USP, CII
0406-2224-012020-07-22C16284748780-1ab0e2407-273b-f274-e053-dbdaa90a6471Levorphanol Tartrate Tablets USP, CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-2224-01Levorphanol Tartrate100 in 1 BOTTLE, PLASTICTABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-2224-01EA - Each0406-22249294750f-f242-4d56-b7e2-c8aa82e0bf6512020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-2224LEVORPHANOL TARTRATE TABLET [SPECGX LLC]15Current NDC, Legacy NDC, 1 package rows20240815_759c7040-0be0-4d17-be97-e467e423eaa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197873levorphanol tartrate 2 MG Oral TabletPSN759c7040-0be0-4d17-be97-e467e423eaa818
197873levorphanol tartrate 2 MG Oral TabletSCD759c7040-0be0-4d17-be97-e467e423eaa818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-2224-0100406222401100 TABLET in 1 BOTTLE, PLASTIC (0406-2224-01) 100 tablet2019-12-130000-00-00NoNoCurrent