LEVOTHYROXINE SODIUM

Product NDC
72189-107
11-digit product format
721890107
Labeler code
72189
Product ID
72189-107_1922dbd9-96de-8652-e063-6294a90a0afe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA209713
Marketing category
ANDA
Marketing start
2020-05-18
Substance
LEVOTHYROXINE SODIUM
Active strength
.075 mg/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM.075 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 · 9 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5f15022-1166-09fe-e053-2a95a90aa218Available 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
72189-107-30LEVOTHYROXINE SODIUM30 in 1 BOTTLETABLET3021
72189-107-90LEVOTHYROXINE SODIUM90 in 1 BOTTLETABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-107-30EA - Each72189-107a36abdad-013a-4259-8241-7dc85ceded4612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-107LEVOTHYROXINE SODIUM TABLET [DIRECT RX]21Current NDC, Legacy NDC, 2 package rows20240524_a5f15022-1166-09fe-e053-2a95a90aa218.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-107-307218901073030 TABLET in 1 BOTTLE (72189-107-30) 30 tablet2020-05-180000-00-00NoNoCurrent
72189-107-907218901079090 TABLET in 1 BOTTLE (72189-107-90) 90 tablet2020-05-180000-00-00NoNoCurrent