Levothyroxine sodium

Product NDC
68788-7944
Requested package NDC
68788-7944-1
11-digit product format
687887944
Labeler code
68788
Product ID
68788-7944_ba0471aa-e839-43e0-a807-e256c76df4d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212399
Marketing category
ANDA
Marketing start
2021-06-28
Substance
LEVOTHYROXINE SODIUM
Active strength
137 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 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
A212399-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-004LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-005LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-006LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-007LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-008LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-009LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-010LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-011LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-012LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A212399-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-008LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-009LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-010LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-011LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…
2026-08-01 22:54:322026-06A212399-012LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212399-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-001AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-001AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-001AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-002AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-002AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-002AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-003AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-003AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-003AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-004AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-004AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-004AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-004AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-005AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-005AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-005AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-005AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-006AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-006AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-006AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-006AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-007AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-007AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-007AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-007AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-008AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-008AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-008AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-008AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-009AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-009AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-009AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-009AB44a50c72e98297…
2026-08-01 22:54:322026-06A212399-010AB11a50c72e98297…
2026-08-01 22:54:322026-06A212399-010AB22a50c72e98297…
2026-08-01 22:54:322026-06A212399-010AB33a50c72e98297…
2026-08-01 22:54:322026-06A212399-010AB44a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.4f40db1e-3dd9-4c7b-93e6-64f0fd10d5512026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.6d65b528-f52b-4b5d-8b76-46fbd4576f992026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (package): 68788-7944-1
ndc (product): 68788-7944
ndc11 (package): 68788794401
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.c38c3c31-6834-4590-ace0-f525e5599f662026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.83854522-f22e-491f-8392-c8b1f94417602026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.633b3f9c-9578-4e07-a515-aec1a8b65e922026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.0cffbc96-7a02-4538-9966-b69249be6eb22026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack775ef7ba-0b5b-40ba-ac7b-2aef121fe4f42026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack231fcdf8-c642-4074-8be8-53ee9c918f182026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack251e65e0-6925-4984-9df9-d6d7c6d0703c2026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack741a8b30-86e1-4f37-917a-73265a82ee072026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.4a2c8e57-d52d-409f-83d8-731b721bf6132026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackf347d92a-7726-4165-bc3c-f5b37ec86f9f2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.f8c14539-8ed1-406a-9b58-8ba3a7ce7ee32026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.55cebc88-0514-4940-b974-ec7f0467d10e2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.c7d5b71b-e983-4b1a-bfc2-d2343cf8668c2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsa0fa8fa5-d3bd-4e52-9ec5-5fb84702826d2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions70853a82-ba3b-4663-9f78-6791ca72ba9f2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions7c8a6441-3c12-46ae-bb3b-a320d80045b62026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions008de8fd-150f-4022-8ccb-c8bfa94875c72026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions67f46137-afc4-471b-a6c7-9c2aef92da5d2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM137 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9J765S329GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
6d65b528-f52b-4b5d-8b76-46fbd4576f99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7944-1Levothyroxine sodium100 in 1 BOTTLETABLET1006
68788-7944-3Levothyroxine sodium30 in 1 BOTTLETABLET306
68788-7944-9Levothyroxine sodium90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7944-1EA - Each68788-7944ef7bcfba-95f5-48d0-a9d1-3a2b2fb5210f12022-11-07
68788-7944-3EA - Each68788-79445cc87cee-623c-4d3b-8419-6b2a8c05247e12022-11-07
68788-7944-9EA - Each68788-79443e3dcb50-8a70-4b88-9d10-3f02548f9d1b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7944LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20240615_6d65b528-f52b-4b5d-8b76-46fbd4576f99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966270levothyroxine sodium 137 MCG Oral TabletPSN6d65b528-f52b-4b5d-8b76-46fbd4576f996
966270levothyroxine sodium 0.137 MG Oral TabletSCD6d65b528-f52b-4b5d-8b76-46fbd4576f996
966270levothyroxine sodium 137 MCG Oral TabletSY6d65b528-f52b-4b5d-8b76-46fbd4576f996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7944-168788794401100 TABLET in 1 BOTTLE (68788-7944-1) 100 tablet2021-06-280000-00-00NoNoCurrent