Levothyroxine Sodium

Product NDC
69238-1840
11-digit product format
692381840
Labeler code
69238
Product ID
69238-1840_3a92e520-3da8-43be-9be2-63511c44b735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
NDA021210
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-12-01
Substance
LEVOTHYROXINE SODIUM
Active strength
.2 mg/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
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 · 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM.2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9J765S329GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
892246Internal RxNorm lookup
892251Internal RxNorm lookup
892255Internal RxNorm lookup
966220Internal RxNorm lookup
966221Internal RxNorm lookup
966222Internal RxNorm lookup
966224Internal RxNorm lookup
966225Internal RxNorm lookup
966248Internal RxNorm lookup
966249Internal RxNorm lookup
966253Internal RxNorm lookup
966270Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fca88c97-5cd4-4834-ba87-deb5bd637788Available on FDA.report

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1840-1Levothyroxine Sodium100 in 1 BOTTLE, PLASTICTABLET10010
69238-1840-7Levothyroxine Sodium1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1840-1EA - Each69238-18401a39d8a8-91fd-496d-934b-2e5f516d9bb812018-12-13
69238-1840-7EA - Each69238-184073d69f86-4bb7-434d-8659-bdbf2a192b0712018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1840LEVOTHYROXINE SODIUM TABLET [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 2 package rows20241208_fca88c97-5cd4-4834-ba87-deb5bd637788.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
ndc (product): 69238-1840
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
892246levothyroxine sodium 100 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966248levothyroxine sodium 112 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966224levothyroxine sodium 125 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966270levothyroxine sodium 137 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966225levothyroxine sodium 150 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966249levothyroxine sodium 175 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
892251levothyroxine sodium 200 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966220levothyroxine sodium 25 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
892255levothyroxine sodium 300 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966221levothyroxine sodium 50 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966222levothyroxine sodium 75 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966253levothyroxine sodium 88 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966220levothyroxine sodium 0.025 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966221levothyroxine sodium 0.05 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966222levothyroxine sodium 0.075 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966253levothyroxine sodium 0.088 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
892246levothyroxine sodium 0.1 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966248levothyroxine sodium 0.112 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966224levothyroxine sodium 0.125 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966270levothyroxine sodium 0.137 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966225levothyroxine sodium 0.15 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966249levothyroxine sodium 0.175 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
892251levothyroxine sodium 0.2 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
892255levothyroxine sodium 0.3 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
892246levothyroxine sodium 100 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966248levothyroxine sodium 112 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966224levothyroxine sodium 125 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966270levothyroxine sodium 137 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966225levothyroxine sodium 150 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966249levothyroxine sodium 175 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
892251levothyroxine sodium 200 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966220levothyroxine sodium 25 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
892255levothyroxine sodium 300 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966221levothyroxine sodium 50 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966222levothyroxine sodium 75 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966253levothyroxine sodium 88 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
892251levothyroxine sodium 200 MCG Oral TabletPSNd4b2c112-68dc-4df0-a511-b7ac6e9efd822
892251levothyroxine sodium 0.2 MG Oral TabletSCDd4b2c112-68dc-4df0-a511-b7ac6e9efd822
892251levothyroxine sodium 200 MCG Oral TabletSYd4b2c112-68dc-4df0-a511-b7ac6e9efd822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1840-169238184001100 TABLET in 1 BOTTLE, PLASTIC (69238-1840-1) 100 tablet2003-12-010000-00-00NoNoCurrent
69238-1840-7692381840071000 TABLET in 1 BOTTLE, PLASTIC (69238-1840-7) 1000 tablet2003-12-010000-00-00NoNoCurrent