Liothyronine Sodium

Product NDC
42794-020
Requested package NDC
42794-020-02
11-digit product format
427940020
Labeler code
42794
Product ID
42794-020_f1f181e3-ceed-1d17-e053-2995a90af5cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liothyronine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
SIGMAPHARM LABORATORIES, LLC
Application
ANDA200295
Marketing category
ANDA
Marketing start
2012-12-03
Substance
LIOTHYRONINE SODIUM
Active strength
50 ug/1
Pharmacologic classes
Triiodothyronine [CS], l-Triiodothyronine [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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200295-001LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29
A200295-002LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29
A200295-003LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A200295-001AB
A200295-002AB
A200295-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200295-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200295-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200295-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200295-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200295-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200295-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200295-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200295-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200295-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200295-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIOTHYRONINE SODIUM50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GCA9VV7D2NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
903456Internal RxNorm lookup
903697Internal RxNorm lookup
903703Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
38ef3766-bb9a-402e-9e4a-ad8bb5b26e4cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b42496cd-a994-8ba1-597f-e507aa62246eProduct name520250116
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42794-020-02Liothyronine Sodium100 in 1 BOTTLETABLET1009
42794-020-12Liothyronine Sodium90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42794-020-02EA - Each42794-0202ba1b65c-6542-4b05-b579-d82fc95c70da12013-02-13
42794-020-12EA - Each42794-020ac0467e6-338b-4f81-91b3-a4995d32c84412018-05-09

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-020LIOTHYRONINE SODIUM TABLET [SIGMAPHARM LABORATORIES, LLC]9Current NDC, Legacy NDC, 2 package rows20230111_38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liothyronine SodiumLIOTHYRONINE SODIUMPreferred Pharmaceuticals Inc.57744c7c-af44-4bc4-a5a8-79f05710f4692026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMASCLEMED USA INC.26cf6872-f4d4-41dd-8957-a000f13efbb32026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
LiomnyLIOTHYRONINE SODIUMSIGMAPHARM LABORATORIES, LLC0dcec611-2b7a-4cf3-80c3-7389be2f0a942025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMPD-Rx Pharmaceuticals, Inc.76fa4eb6-fefa-4e97-9543-f81e465743e62025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMNuCare Pharmaceuticals,Inc.1133ebe8-38c2-2505-e063-6294a90aaa2f2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMA-S Medication Solutionsdb65bcd8-e9c9-4095-9975-03be1f4438232024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMBryant Ranch Prepack31a11006-8122-49fc-8769-a28a359ac5262023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMBryant Ranch Prepack7efdd16d-37e6-4dc8-a6c5-5b42c48133792023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMBryant Ranch Prepack20cbf84d-80f2-4b94-ad47-6aaa362fb4d02023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMProficient Rx LPf882d34f-6b9f-4d9d-8a3e-3054ba91c5062023-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMSIGMAPHARM LABORATORIES, LLC38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c2023-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
ndc (package): 42794-020-02
ndc (product): 42794-020
ndc11 (package): 42794002002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903703liothyronine sodium 50 MCG Oral TabletPSN20cbf84d-80f2-4b94-ad47-6aaa362fb4d0101
903703liothyronine sodium 0.05 MG Oral TabletSCD20cbf84d-80f2-4b94-ad47-6aaa362fb4d0101
903703liothyronine sodium 50 MCG Oral TabletSY20cbf84d-80f2-4b94-ad47-6aaa362fb4d0101
903697liothyronine sodium 25 MCG Oral TabletPSN38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903456liothyronine sodium 5 MCG Oral TabletPSN38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903703liothyronine sodium 50 MCG Oral TabletPSN38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903456liothyronine sodium 0.005 MG Oral TabletSCD38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903697liothyronine sodium 0.025 MG Oral TabletSCD38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903703liothyronine sodium 0.05 MG Oral TabletSCD38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903697liothyronine sodium 25 MCG Oral TabletSY38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903456liothyronine sodium 5 MCG Oral TabletSY38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903703liothyronine sodium 50 MCG Oral TabletSY38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c9
903697liothyronine sodium 25 MCG Oral TabletPSN26cf6872-f4d4-41dd-8957-a000f13efbb31
903456liothyronine sodium 5 MCG Oral TabletPSN26cf6872-f4d4-41dd-8957-a000f13efbb31
903703liothyronine sodium 50 MCG Oral TabletPSN26cf6872-f4d4-41dd-8957-a000f13efbb31
903456liothyronine sodium 0.005 MG Oral TabletSCD26cf6872-f4d4-41dd-8957-a000f13efbb31
903697liothyronine sodium 0.025 MG Oral TabletSCD26cf6872-f4d4-41dd-8957-a000f13efbb31
903703liothyronine sodium 0.05 MG Oral TabletSCD26cf6872-f4d4-41dd-8957-a000f13efbb31
903697liothyronine sodium 25 MCG Oral TabletSY26cf6872-f4d4-41dd-8957-a000f13efbb31
903456liothyronine sodium 5 MCG Oral TabletSY26cf6872-f4d4-41dd-8957-a000f13efbb31
903703liothyronine sodium 50 MCG Oral TabletSY26cf6872-f4d4-41dd-8957-a000f13efbb31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42794-020-0242794002002100 TABLET in 1 BOTTLE (42794-020-02) 100 tablet2012-12-030000-00-00NoNoCurrent