Levothyroxine Sodium

Product NDC
51655-924
11-digit product format
516550924
Labeler code
51655
Product ID
51655-924_4bbd6cef-71c9-d780-e063-6394a90aa90c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA209713
Marketing category
ANDA
Marketing start
2022-03-04
Substance
LEVOTHYROXINE SODIUM
Active strength
.05 mg/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
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 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209713-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-004LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-005LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-006LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-007LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-008LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-009LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-010LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-011LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18
A209713-012LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18

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 UTC2026-02A209713-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-008LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-009LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-010LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-011LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-012LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-008LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-009LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-010LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-011LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-012LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209713-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-008LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-009LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-010LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-011LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209713-012LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209713-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209713-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209713-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209713-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32019-01-18fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 36 · 1,428 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209713-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-001AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-001AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-002AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-002AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-003AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-003AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-004AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-004AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-004AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-005AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-005AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-005AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-006AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-006AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-006AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-007AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-007AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-007AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-008AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-008AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-008AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-009AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-009AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-009AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-010AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-010AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-010AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-011AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-011AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-011AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-012AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-012AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209713-012AB33011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-001AB2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-001AB3331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209713-002AB1131067a03dcf5…

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM.05 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
966221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9dff641-ced3-bae3-e053-2a95a90a2e29Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-924-52Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-924LEVOTHYROXINE SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20240814_d9dff641-ced3-bae3-e053-2a95a90a2e29.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 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC55f4c679-86cb-b97f-e063-6294a90ad5ef2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC55f67831-4680-edbf-e063-6294a90a1d362026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC544d67eb-8487-cb5d-e063-6394a90a31102026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC53e84179-fe2a-5696-e063-6394a90a85662026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC53316e75-9897-4935-e063-6294a90a94cf2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsc8ae9dc4-836f-4912-80d7-684fd374f40a2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC52cce695-4363-8a2c-e063-6294a90a1bbf2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC52cd19e4-a4b3-ecee-e063-6394a90ac33b2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC51b68266-95d2-c166-e063-6294a90a534f2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC50fe00b3-6610-1cac-e063-6294a90af8ac2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC5100c561-0028-a3c0-e063-6394a90addeb2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPf94a81e2-49cd-430a-acda-1a47d5c5b59b2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP0235176b-ec39-44c4-a9e1-e0729a7989fa2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP7d07e932-7372-4c17-aa53-55087107fa522026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack2ecaa38f-8a6f-4536-8033-251d2c52ae642026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions991399a4-ff94-44d0-b1ba-1f89e77594982026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions87333260-fe57-4d99-886c-7c66cb0638982026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions99df68ea-4de7-4825-a6d7-894c70d01c282026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions4f26f9dc-cf49-4b55-a6f7-f2f579893ee42026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCffc34bc6-5de5-addb-e053-6294a90a25be2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209713
application number: ANDA209713

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966221levothyroxine sodium 50 MCG Oral TabletPSNd9dff641-ced3-bae3-e053-2a95a90a2e296
966221levothyroxine sodium 0.05 MG Oral TabletSCDd9dff641-ced3-bae3-e053-2a95a90a2e296
966221levothyroxine sodium 50 MCG Oral TabletSYd9dff641-ced3-bae3-e053-2a95a90a2e296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-924-525165509245230 TABLET in 1 BOTTLE, PLASTIC (51655-924-52) 30 tablet2022-03-040000-00-00NoNoCurrent