Levothyroxine Sodium

Product NDC
51655-583
11-digit product format
516550583
Labeler code
51655
Product ID
51655-583_4b7f6e44-dac8-1950-e063-6394a90a565c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
NDA021342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-03-30
Substance
LEVOTHYROXINE SODIUM
Active strength
150 ug/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 43.

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
N021342-001LEVO-TLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-002LEVO-TLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-003LEVO-TLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-004LEVO-TLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-005LEVO-TLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-006LEVO-TLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-007LEVO-TLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-008LEVO-TLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-009LEVO-TLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-010LEVO-TLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-011LEVO-TLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01
N021342-012LEVO-TLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32003-12-08

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 · 516 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021342-001LEVO-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-002LEVO-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-003LEVO-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-004LEVO-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-005LEVO-T0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-006LEVO-T0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-007LEVO-T0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-008LEVO-T0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-009LEVO-T0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-010LEVO-T0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-011LEVO-T0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08N021342-012LEVO-T0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32003-12-0884e616aacf4f…
2026-08-18 06:07:402026-07N021342-001LEVO-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-002LEVO-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-003LEVO-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-004LEVO-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-005LEVO-T0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-006LEVO-T0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-007LEVO-T0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-008LEVO-T0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-009LEVO-T0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-010LEVO-T0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-011LEVO-T0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-012LEVO-T0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32003-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021342-001LEVO-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-002LEVO-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-003LEVO-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-004LEVO-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-005LEVO-T0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-006LEVO-T0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-007LEVO-T0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-008LEVO-T0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-009LEVO-T0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-010LEVO-T0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-011LEVO-T0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021342-012LEVO-T0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32003-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021342-001LEVO-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021342-002LEVO-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021342-003LEVO-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021342-004LEVO-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB32002-03-0131067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 39 · 1,548 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021342-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-001AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-001AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-002AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-002AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-003AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-003AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-004AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-004AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-004AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-005AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-005AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-005AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-006AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-006AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-006AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-007AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-007AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-007AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-008AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-008AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-008AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-009AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-009AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-009AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-010AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-010AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-010AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-011AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-011AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-011AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021342-012AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021342-012AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021342-012AB3384e616aacf4f…
2026-08-18 06:07:402026-07N021342-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-001AB22caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-001AB33caaa826d4ba7…
2026-08-18 06:07:402026-07N021342-002AB11caaa826d4ba7…

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021342-00163991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00263991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00363991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00463991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00563991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00663991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00763991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00863991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-00963991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-01063991012020-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021342-01163991012020-03-3074a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021342-00163991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00263991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00363991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00463991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00563991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00663991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00763991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00863991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-00963991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-01063991012020-03-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021342-01163991012020-03-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021342-00163991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00263991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00363991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00463991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00563991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00663991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00763991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00863991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-00963991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-01063991012020-03-30c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021342-01163991012020-03-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021342-00163991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00263991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00363991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00463991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00563991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00663991012020-03-303f01610625f2…
2019-12-14 00:12 UTC2019-12N021342-00763991012020-03-303f01610625f2…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM150 ug/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
966225Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f86efc89-f784-c8bb-e053-6294a90a63c9Available 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
51655-583-52Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-583LEVOTHYROXINE SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230407_f86efc89-f784-c8bb-e053-6294a90a63c9.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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack66bb0ba9-cd63-4817-907f-7b8ad5dc66852026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8ac112c3-1e06-4fdb-a7af-2ee988de5b152026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack69fb5cd6-90ba-487d-a754-07c664a1fdd12026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf6c92836-95e1-1402-e053-6394a90a2f5e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMLannett Company, Inca8db0f7d-8863-9309-e053-2995a90a284a2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf31b5d54-7536-4290-e053-2a95a90ac2352026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf32b4a01-edea-fc85-e053-2995a90ac1752026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf31a35cb-fc54-8872-e053-2a95a90ad8e72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf31ba297-e042-187a-e053-2a95a90a48612026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf31d987d-6836-b4a7-e053-2a95a90a8f7b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf86e74e1-0d55-8d0e-e053-6394a90a07bf2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf86efc89-f784-c8bb-e053-6294a90a63c92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
ndc (product): 51655-583
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb9821db-3fe3-d1cf-e053-2a95a90a02522026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf86fab39-bbd9-a51c-e053-6294a90accd02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC472ec9e7-c1db-bf8c-e063-6394a90a2c072025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC4302e36f-0b5b-f645-e063-6394a90a010f2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP9e588c43-b9b5-478e-99f7-e197add3cd262025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions91afb351-f067-49a2-bdf0-336ea209718d2025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions237cc591-c40b-416f-ac00-96cd61bc59dc2025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8f83fd60-5aa7-4e7f-a6e9-917e2c1abf272024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021342
application number: NDA021342

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966225levothyroxine sodium 150 MCG Oral TabletPSNf86efc89-f784-c8bb-e053-6294a90a63c96
966225levothyroxine sodium 0.15 MG Oral TabletSCDf86efc89-f784-c8bb-e053-6294a90a63c96
966225levothyroxine sodium 150 MCG Oral TabletSYf86efc89-f784-c8bb-e053-6294a90a63c96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-583-525165505835230 TABLET in 1 BOTTLE, PLASTIC (51655-583-52) 30 tablet2023-03-30NoNoCurrent