Levothyroxine Sodium

Product NDC
50090-4057
Requested package NDC
50090-4057-1
11-digit product format
500904057
Labeler code
50090
Product ID
50090-4057_9138d770-e647-44a0-b9d3-f6b6b3f6eb41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021210
Marketing category
NDA
Marketing start
2003-12-01
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
0 mg/1
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-405750090-4057-1IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021210-001UNITHROIDLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-002UNITHROIDLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-003UNITHROIDLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-004UNITHROIDLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-005UNITHROIDLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-006UNITHROIDLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-007UNITHROIDLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-008UNITHROIDLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-009UNITHROIDLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-010UNITHROIDLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-011UNITHROIDLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD, RS2000-08-21
N021210-012UNITHROIDLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2008-02-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 36 matching rows.

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 13 · 492 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021210-001UNITHROID0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-002UNITHROID0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-003UNITHROID0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-004UNITHROID0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-005UNITHROID0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-006UNITHROID0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-007UNITHROID0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-008UNITHROID0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-009UNITHROID0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-010UNITHROID0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-011UNITHROID0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD, RS2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-012UNITHROID0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2008-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-001UNITHROID0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-002UNITHROID0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-003UNITHROID0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-004UNITHROID0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-005UNITHROID0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-006UNITHROID0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-007UNITHROID0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-008UNITHROID0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-009UNITHROID0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-010UNITHROID0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-011UNITHROID0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD, RS2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-012UNITHROID0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2008-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021210-001UNITHROID0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-002UNITHROID0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-003UNITHROID0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-004UNITHROID0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-005UNITHROID0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-006UNITHROID0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-007UNITHROID0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-008UNITHROID0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-009UNITHROID0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-010UNITHROID0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-011UNITHROID0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD, RS2000-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021210-012UNITHROID0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2008-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021210-001UNITHROID0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021210-002UNITHROID0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021210-003UNITHROID0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021210-004UNITHROID0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 37 · 1,476 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021210-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-001AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-001AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-002AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-002AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-003AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-003AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-004AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-004AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-004AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-005AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-005AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-005AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-006AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-006AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-006AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-007AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-007AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-007AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-008AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-008AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-008AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-009AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-009AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-009AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-010AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-010AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-010AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-011AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-011AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-011AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-012AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-012AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-012AB33011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-001AB2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-001AB3331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-002AB1131067a03dcf5…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4057-02023-01-30C16284748780-1f386c649-fa4c-0266-e053-dadaa90a7c1aLevothyroxine Sodium Tablets, USP
50090-4057-12023-01-30C16284748780-1f386c649-fa4c-0266-e053-dadaa90a7c1aLevothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4057-0Levothyroxine Sodium30 in 1 BOTTLETABLET303
50090-4057-1Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4057LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20190501_c4e363f2-2632-4c00-904d-0b467cc09acc.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMNCS HealthCare of KY, LLC dba Vangard Labsabe173cc-1579-43a5-b12d-a31958d0a5392026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCc968836a-f94c-4d13-e053-2995a90a8df52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
Levothyroxine SodiumLEVOTHYROXINE SODIUMAmneal Pharmaceuticals NY LLCfca88c97-5cd4-4834-ba87-deb5bd6377882024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP2f0657d5-3e5c-4249-bfaa-7f5ef15286722021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP97e28b00-9913-463f-9de2-08c828edbe672020-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP05ab038e-45fa-488e-a05e-12a2dd3564c12020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPb81720f9-2836-4c1d-8691-0f6acef133162020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP434075d5-a82b-4f17-85e6-4c1922663dbc2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP18c7c63a-642e-47fe-a8ee-12aaf652b2aa2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210
UnithroidLEVOTHYROXINE SODIUMAmneal Pharmaceuticals LLC07562e72-7eaa-4ce6-94f0-e08814787e502019-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021210
application number: NDA021210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966253levothyroxine sodium 88 MCG Oral TabletPSNc4e363f2-2632-4c00-904d-0b467cc09acc3
966253levothyroxine sodium 0.088 MG Oral TabletSCDc4e363f2-2632-4c00-904d-0b467cc09acc3
966253levothyroxine sodium 88 MCG Oral TabletSYc4e363f2-2632-4c00-904d-0b467cc09acc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4057-15009040570190 TABLET in 1 BOTTLE, PLASTIC (50090-4057-1) 90 tablet2014-11-280000-00-00NoNoCurrent