LEVOXYL

Product NDC
60793-856
Requested package NDC
60793-856-01
11-digit product format
607930856
Labeler code
60793
Product ID
60793-856_e230c170-2a16-47d0-bce7-ac0414c192f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA021301
Marketing category
NDA
Marketing start
2001-05-25
Substance
LEVOTHYROXINE SODIUM
Active strength
125 ug/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
N021301-001LEVOXYLLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-002LEVOXYLLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-003LEVOXYLLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-004LEVOXYLLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-005LEVOXYLLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-006LEVOXYLLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-007LEVOXYLLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-008LEVOXYLLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-009LEVOXYLLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-010LEVOXYLLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25
N021301-011LEVOXYLLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD, RS2001-05-25
N021301-012LEVOXYLLEVOTHYROXINE SODIUM0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 22 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 UTC2026-02N021301-001LEVOXYL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-002LEVOXYL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-003LEVOXYL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-004LEVOXYL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-005LEVOXYL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-006LEVOXYL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-007LEVOXYL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-008LEVOXYL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-009LEVOXYL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-010LEVOXYL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-011LEVOXYL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD, RS2001-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-012LEVOXYL0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-001LEVOXYL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-002LEVOXYL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-003LEVOXYL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-004LEVOXYL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-005LEVOXYL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-006LEVOXYL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-007LEVOXYL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-008LEVOXYL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-009LEVOXYL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-010LEVOXYL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-011LEVOXYL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD, RS2001-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-012LEVOXYL0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021301-001LEVOXYL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-002LEVOXYL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-003LEVOXYL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-004LEVOXYL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-005LEVOXYL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-006LEVOXYL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-007LEVOXYL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-008LEVOXYL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-009LEVOXYL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-010LEVOXYL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-011LEVOXYL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD, RS2001-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021301-012LEVOXYL0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021301-001LEVOXYL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021301-002LEVOXYL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021301-003LEVOXYL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021301-004LEVOXYL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB3RLD2001-05-25fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 23 · 902 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021301-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-001AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-002AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-003AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-004AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-004AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-005AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-005AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-006AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-006AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-007AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-007AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-008AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-008AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-009AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-009AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-010AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-010AB32011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-011AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021301-011AB32011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-001AB3231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-002AB3231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-003AB3231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-004AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-004AB3231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-005AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-005AB3231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-006AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-006AB3231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-007AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-007AB3231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-008AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-008AB3231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-009AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021301-009AB3231067a03dcf5…

Observed Orange Book patent history#

Patent history page 1 of 18 · 720 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00165555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00170671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00171015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00265555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00270671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00271015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00365555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00370671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00371015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00465555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00470671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00471015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00565555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00570671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00571015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00665555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00670671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00671015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00765555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00770671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00771015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00865555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00870671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00871015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00965555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00970671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-00971015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01065555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01070671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01071015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01165555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01170671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01171015692023-10-02U-7595c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01265555812022-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01270671482022-02-15Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021301-01271015692023-10-02U-7595c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021301-00165555812022-02-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021301-00170671482022-02-15Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021301-00171015692023-10-02U-7595d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021301-00265555812022-02-155d02ea3f76ae…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM125 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 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
892246Internal RxNorm lookup
892251Internal RxNorm lookup
966157Internal RxNorm lookup
966164Internal RxNorm lookup
966170Internal RxNorm lookup
966175Internal RxNorm lookup
966184Internal RxNorm lookup
966190Internal RxNorm lookup
966194Internal RxNorm lookup
966200Internal RxNorm lookup
966204Internal RxNorm lookup
966211Internal 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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
758588c3-c63e-491b-0aa2-4f50d80cb174Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60793-856-01LEVOXYL100 in 1 BOTTLETABLET10012
60793-856-10LEVOXYL1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60793-856-01EA - Each60793-8565fbd473a-e69a-4354-8cf4-5872a9e0e98f12012-07-24
60793-856-10EA - Each60793-8567b7390b8-ebf3-4615-a789-a47260940edb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PFIZER LABORATORIES DIV PFIZER INC]7
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PFIZER LABORATORIES DIV PFIZER INC]7
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60793-856LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PFIZER LABORATORIES DIV PFIZER INC]12Current NDC, Legacy NDC, 2 package rows20201216_758588c3-c63e-491b-0aa2-4f50d80cb174.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVOXYLLEVOTHYROXINE SODIUMPfizer Laboratories Div Pfizer Inc758588c3-c63e-491b-0aa2-4f50d80cb1742020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021301
application number: NDA021301
ndc (package): 60793-856-01
ndc (product): 60793-856
ndc11 (package): 60793085601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966248levothyroxine sodium 112 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966224levothyroxine sodium 125 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966270levothyroxine sodium 137 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966225levothyroxine sodium 150 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966249levothyroxine sodium 175 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
892251levothyroxine sodium 200 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966220levothyroxine sodium 25 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966221levothyroxine sodium 50 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966222levothyroxine sodium 75 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966253levothyroxine sodium 88 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966283LEVOXYL 100 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966184LEVOXYL 112 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966190LEVOXYL 125 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966194LEVOXYL 137 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966200LEVOXYL 150 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966204LEVOXYL 175 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966211LEVOXYL 200 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966157LEVOXYL 25 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966164LEVOXYL 50 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966170LEVOXYL 75 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966175LEVOXYL 88 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966157levothyroxine sodium 0.025 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966164levothyroxine sodium 0.05 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966170levothyroxine sodium 0.075 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966175levothyroxine sodium 0.088 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966283levothyroxine sodium 0.1 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966184levothyroxine sodium 0.112 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966190levothyroxine sodium 0.125 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966194levothyroxine sodium 0.137 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966200levothyroxine sodium 0.15 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966204levothyroxine sodium 0.175 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966211levothyroxine sodium 0.2 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966220levothyroxine sodium 0.025 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966221levothyroxine sodium 0.05 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966222levothyroxine sodium 0.075 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966253levothyroxine sodium 0.088 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
892246levothyroxine sodium 0.1 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966248levothyroxine sodium 0.112 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966224levothyroxine sodium 0.125 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966270levothyroxine sodium 0.137 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966225levothyroxine sodium 0.15 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966249levothyroxine sodium 0.175 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
892251levothyroxine sodium 0.2 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
892246levothyroxine sodium 100 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966248levothyroxine sodium 112 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966224levothyroxine sodium 125 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966270levothyroxine sodium 137 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966225levothyroxine sodium 150 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966249levothyroxine sodium 175 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
892251levothyroxine sodium 200 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966220levothyroxine sodium 25 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966221levothyroxine sodium 50 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966222levothyroxine sodium 75 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966253levothyroxine sodium 88 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966157Levoxyl 0.025 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966164Levoxyl 0.05 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966170Levoxyl 0.075 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966175Levoxyl 0.088 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966283Levoxyl 0.1 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966184Levoxyl 0.112 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966190Levoxyl 0.125 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966194Levoxyl 0.137 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966200Levoxyl 0.15 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966204Levoxyl 0.175 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966211Levoxyl 0.2 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966283Levoxyl 100 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966184Levoxyl 112 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966190Levoxyl 125 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966194Levoxyl 137 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966200Levoxyl 150 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966204Levoxyl 175 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966211Levoxyl 200 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966157Levoxyl 25 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966164Levoxyl 50 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966170Levoxyl 75 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966175Levoxyl 88 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
892246levothyroxine sodium 100 MCG Oral TabletPSN951c6e16-7251-42ed-ac19-d8367a6aee4f5
966248levothyroxine sodium 112 MCG Oral TabletPSN951c6e16-7251-42ed-ac19-d8367a6aee4f5
966224levothyroxine sodium 125 MCG Oral TabletPSN951c6e16-7251-42ed-ac19-d8367a6aee4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60793-856-0160793085601100 TABLET in 1 BOTTLE (60793-856-01) 100 tablet2001-05-250000-00-00NoNoCurrent