levothyroxine sodium

Product NDC
47781-640
Requested package NDC
47781-640-10
11-digit product format
477810640
Labeler code
47781
Product ID
47781-640_12e236b4-dc71-96ce-cdd3-7bede41b3f1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen, Inc.
Application
NDA021116
Marketing category
NDA
Marketing start
2019-05-07
Substance
LEVOTHYROXINE SODIUM
Active strength
25 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
N021116-001THYRO-TABSLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-002THYRO-TABSLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-003THYRO-TABSLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-004THYRO-TABSLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-005THYRO-TABSLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-006THYRO-TABSLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-007THYRO-TABSLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-008THYRO-TABSLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-009THYRO-TABSLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-010THYRO-TABSLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-011THYRO-TABSLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24
N021116-012THYRO-TABSLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2004-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 48 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 UTC2026-02N021116-001THYRO-TABS0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-002THYRO-TABS0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-003THYRO-TABS0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-004THYRO-TABS0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-005THYRO-TABS0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-006THYRO-TABS0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-007THYRO-TABS0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-008THYRO-TABS0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-009THYRO-TABS0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-010THYRO-TABS0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-011THYRO-TABS0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-012THYRO-TABS0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2004-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-001THYRO-TABS0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-002THYRO-TABS0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-003THYRO-TABS0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-004THYRO-TABS0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-005THYRO-TABS0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-006THYRO-TABS0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-007THYRO-TABS0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-008THYRO-TABS0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-009THYRO-TABS0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-010THYRO-TABS0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-011THYRO-TABS0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021116-012THYRO-TABS0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2004-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021116-001THYRO-TABS0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-002THYRO-TABS0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-003THYRO-TABS0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-004THYRO-TABS0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-005THYRO-TABS0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-006THYRO-TABS0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-007THYRO-TABS0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-008THYRO-TABS0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-009THYRO-TABS0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-010THYRO-TABS0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-011THYRO-TABS0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021116-012THYRO-TABS0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2004-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021116-001THYRO-TABS0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021116-002THYRO-TABS0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021116-003THYRO-TABS0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021116-004THYRO-TABS0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAB1,AB2,AB3,AB4RLD2002-10-24fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 43 · 1,716 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021116-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-001AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-001AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-001AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-002AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-002AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-002AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-003AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-003AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-003AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-004AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-004AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-004AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-004AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-005AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-005AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-005AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-005AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-006AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-006AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-006AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-006AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-007AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-007AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-007AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-007AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-008AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-008AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-008AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-008AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-009AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-009AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-009AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-009AB44011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-010AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-010AB22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-010AB33011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021116-010AB44011fe1cb6892…

Additional Listing Data#

Finished product
Yes
Brand name base
levothyroxine sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM25 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ddcaec1-a58f-340b-9bc1-bbe048b8c885Available 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
47781-640-10levothyroxine sodium1000 in 1 BOTTLETABLET10007
47781-640-90levothyroxine sodium90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-640-10EA - Each47781-6409706af98-c9e9-4392-9a60-160005897b2012019-06-19
47781-640-90EA - Each47781-640568576b3-1a56-41ad-9a24-8c465d997eea12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-640LEVOTHYROXINE SODIUM TABLET [ALVOGEN, INC.]6Current NDC, Legacy NDC, 2 package rows20240317_4ddcaec1-a58f-340b-9bc1-bbe048b8c885.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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack3b282e57-1009-4d2c-8ca2-9cca9f7919372026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.eb53dc23-8337-497e-b466-192f905563ed2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.3519c765-2077-4f23-8644-a6242ddbf7432026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.ac10b751-5195-4987-a841-400ae79730f02026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.645c52bb-c46e-426e-91d4-151aeac975a72026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.65c8b305-8ffb-4aa5-aca1-f4e4ead71a9c2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsf2bed4e7-86e9-430e-80d9-7bd7cfcf9bf52026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions8f7dc71e-4a48-4ba5-945b-f340ff51636e2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.59a99739-2da5-46a7-8811-1169123bed9b2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.579b1935-77f5-4381-9cb0-e0130e4834e82026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.4e6dce46-cbf5-4353-9d0c-36b6f857197a2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb5dd9d2-4f96-25d0-e053-2995a90af9dc2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCc9f4923e-5625-1d4f-e053-2a95a90aabc92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb89c58f-9dd0-b6d6-e053-2a95a90ae2e72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack48c29432-a36c-4787-a05f-8d25a0abcc372025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP00a4fc0b-7162-455e-8ed3-56efdbbe182e2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackc1b0fbad-5816-4152-ab59-05079e8c21482025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack9e3bffb9-f66e-4c73-befc-e60d769f66102025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.398a00d0-1247-4f6f-b4c1-dade399cc4172025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.412fc3f4-d9e0-49c5-b042-a6010aea7e5e2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021116
application number: NDA021116

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966220levothyroxine sodium 25 MCG Oral TabletPSNd79526e0-d327-4545-a50c-99678766d817107
966220levothyroxine sodium 0.025 MG Oral TabletSCDd79526e0-d327-4545-a50c-99678766d817107
966220levothyroxine sodium 25 MCG Oral TabletSYd79526e0-d327-4545-a50c-99678766d817107
966220levothyroxine sodium 25 MCG Oral TabletPSN3b282e57-1009-4d2c-8ca2-9cca9f791937102
966220levothyroxine sodium 0.025 MG Oral TabletSCD3b282e57-1009-4d2c-8ca2-9cca9f791937102
966220levothyroxine sodium 25 MCG Oral TabletSY3b282e57-1009-4d2c-8ca2-9cca9f791937102
966220levothyroxine sodium 25 MCG Oral TabletPSN8849620a-5e8d-4031-884f-9a2817b050f2101
966220levothyroxine sodium 0.025 MG Oral TabletSCD8849620a-5e8d-4031-884f-9a2817b050f2101
966220levothyroxine sodium 25 MCG Oral TabletSY8849620a-5e8d-4031-884f-9a2817b050f2101
892246levothyroxine sodium 100 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 112 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 125 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 137 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 150 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 175 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 200 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 25 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 50 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 75 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 88 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 0.025 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 0.05 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 0.075 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 0.088 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 0.1 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 0.112 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 0.125 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 0.137 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 0.15 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 0.175 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 0.2 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 100 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 112 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 125 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 137 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 150 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 175 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 200 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 25 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 50 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 75 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 88 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 100 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966248levothyroxine sodium 112 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966224levothyroxine sodium 125 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966270levothyroxine sodium 137 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966225levothyroxine sodium 150 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966220levothyroxine sodium 25 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966221levothyroxine sodium 50 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966222levothyroxine sodium 75 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966253levothyroxine sodium 88 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966220levothyroxine sodium 0.025 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966221levothyroxine sodium 0.05 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966222levothyroxine sodium 0.075 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966253levothyroxine sodium 0.088 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
892246levothyroxine sodium 0.1 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966248levothyroxine sodium 0.112 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966224levothyroxine sodium 0.125 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966270levothyroxine sodium 0.137 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966225levothyroxine sodium 0.15 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
892246levothyroxine sodium 100 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966248levothyroxine sodium 112 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966224levothyroxine sodium 125 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966270levothyroxine sodium 137 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966225levothyroxine sodium 150 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966220levothyroxine sodium 25 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966221levothyroxine sodium 50 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966222levothyroxine sodium 75 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966253levothyroxine sodium 88 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
892246levothyroxine sodium 100 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966248levothyroxine sodium 112 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966224levothyroxine sodium 125 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966270levothyroxine sodium 137 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966225levothyroxine sodium 150 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966249levothyroxine sodium 175 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892251levothyroxine sodium 200 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966220levothyroxine sodium 25 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892255levothyroxine sodium 300 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966221levothyroxine sodium 50 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966222levothyroxine sodium 75 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-640-10477810640101000 TABLET in 1 BOTTLE (47781-640-10) 1000 tablet2019-05-070000-00-00NoNoCurrent