FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
70860-451
Requested package NDC
70860-451-10
11-digit product format
708600451
Labeler code
70860
Product ID
70860-451_beba3892-9b9f-4786-9ebb-b70076071295
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium anhydrous
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA208749
Marketing category
ANDA
Marketing start
2018-12-15
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM ANHYDROUS
Active strength
100 ug/5mL
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70860-45170860-451-10DDiscontinued by firm2026-07-31

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
A208749-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21
A208749-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21
A208749-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208749-001AP
A208749-002AP
A208749-003AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208749-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21a50c72e98297…
2026-08-01 22:54:322026-06A208749-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21a50c72e98297…
2026-08-01 22:54:322026-06A208749-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208749-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A208749-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A208749-003AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSSagent Pharmaceuticalsf57e9b19-6f17-4520-80fc-511322cc56c92023-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208749
application number: ANDA208749
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSMAIA Pharmaceuticals, Inc.4e9adc35-3aba-4a0d-9c4e-7e7ee2ffdabd2019-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208749
application number: ANDA208749

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-451-102024-03-04C16284748780-11030e365-3679-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM FOR INJECTION safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM FOR INJECTION. LEVOTHYROXINE SODIUM for injection, for intravenous use Initial U.S. Approval: 1969
70860-451-102024-01-30C16284748780-11030e365-3679-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM FOR INJECTION safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM FOR INJECTION. LEVOTHYROXINE SODIUM for injection, for intravenous use Initial U.S. Approval: 1969

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-451-10EA - Each70860-45135183001-9bb4-4767-891f-703ef397a51112019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-451-10708600451101 VIAL in 1 CARTON (70860-451-10) > 5 mL in 1 VIAL1 vial2018-12-150000-00-00NoNoCurrent