Liothyronine sodium

Product NDC
68382-582
11-digit product format
683820582
Labeler code
68382
Product ID
68382-582_04696ad1-0a11-4e94-b4d2-c4b66d688b3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liothyronine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA214803
Marketing category
ANDA
Marketing start
2021-02-01
Substance
LIOTHYRONINE SODIUM
Active strength
5 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
A214803-001LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-22
A214803-002LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-22
A214803-003LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214803-001AB
A214803-002AB
A214803-003AB

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 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214803-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2021-01-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214803-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2021-01-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214803-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2021-01-228072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214803-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214803-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214803-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214803-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214803-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214803-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214803-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214803-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214803-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214803-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214803-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214803-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214803-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214803-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214803-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214803-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214803-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214803-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214803-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214803-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214803-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214803-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214803-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214803-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214803-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214803-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214803-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214803-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214803-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214803-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214803-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214803-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214803-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214803-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214803-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214803-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214803-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214803-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214803-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214803-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIOTHYRONINE SODIUM5 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
c54cf95f-6465-4203-b98b-a54ba5a26843Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b42496cd-a994-8ba1-597f-e507aa62246eProduct name520250116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-582-01Liothyronine sodium100 in 1 BOTTLETABLET1004
68382-582-10Liothyronine sodium1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-582-01EA - Each68382-582fd1ebe2e-9127-4dea-86bd-1980fb1ff7cd12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-582LIOTHYRONINE SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 2 package rows20240814_c54cf95f-6465-4203-b98b-a54ba5a26843.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liothyronine sodiumLIOTHYRONINE SODIUMBryant Ranch Prepackb18e24fd-def0-4ff4-aa08-5f91c03c6f9e2024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214803
application number: ANDA214803
Liothyronine sodiumLIOTHYRONINE SODIUMBryant Ranch Prepack5222f13d-7222-4845-b863-49e7558f5b1a2024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214803
application number: ANDA214803
Liothyronine sodiumLIOTHYRONINE SODIUMZydus Pharmaceuticals (USA) Inc.c54cf95f-6465-4203-b98b-a54ba5a268432024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214803
application number: ANDA214803
ndc (product): 68382-582
Liothyronine sodiumLIOTHYRONINE SODIUMNorthstar Rx LLCc97dc9ec-af73-4836-aa0d-c27e66e792a92024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214803
application number: ANDA214803
Liothyronine sodiumLIOTHYRONINE SODIUMBryant Ranch Prepack9d3633e3-44b7-4f62-9fe4-e5c7c41293452024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214803
application number: ANDA214803
Liothyronine sodiumLIOTHYRONINE SODIUMZydus Lifesciences Limited4fb09346-3d30-4a7c-a97c-480d5924997a2024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214803
application number: ANDA214803
Liothyronine sodiumLIOTHYRONINE SODIUMA-S Medication Solutions52baac91-4b00-40d4-9ca7-8b9405bd415c2023-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214803
application number: ANDA214803

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903456liothyronine sodium 5 MCG Oral TabletPSNb18e24fd-def0-4ff4-aa08-5f91c03c6f9e104
903456liothyronine sodium 0.005 MG Oral TabletSCDb18e24fd-def0-4ff4-aa08-5f91c03c6f9e104
903456liothyronine sodium 5 MCG Oral TabletSYb18e24fd-def0-4ff4-aa08-5f91c03c6f9e104
903456liothyronine sodium 5 MCG Oral TabletPSN52baac91-4b00-40d4-9ca7-8b9405bd415c6
903456liothyronine sodium 0.005 MG Oral TabletSCD52baac91-4b00-40d4-9ca7-8b9405bd415c6
903456liothyronine sodium 5 MCG Oral TabletSY52baac91-4b00-40d4-9ca7-8b9405bd415c6
903697liothyronine sodium 25 MCG Oral TabletPSNc54cf95f-6465-4203-b98b-a54ba5a268434
903456liothyronine sodium 5 MCG Oral TabletPSNc54cf95f-6465-4203-b98b-a54ba5a268434
903703liothyronine sodium 50 MCG Oral TabletPSNc54cf95f-6465-4203-b98b-a54ba5a268434
903456liothyronine sodium 0.005 MG Oral TabletSCDc54cf95f-6465-4203-b98b-a54ba5a268434
903697liothyronine sodium 0.025 MG Oral TabletSCDc54cf95f-6465-4203-b98b-a54ba5a268434
903703liothyronine sodium 0.05 MG Oral TabletSCDc54cf95f-6465-4203-b98b-a54ba5a268434
903697liothyronine sodium 25 MCG Oral TabletSYc54cf95f-6465-4203-b98b-a54ba5a268434
903456liothyronine sodium 5 MCG Oral TabletSYc54cf95f-6465-4203-b98b-a54ba5a268434
903703liothyronine sodium 50 MCG Oral TabletSYc54cf95f-6465-4203-b98b-a54ba5a268434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-582-0168382058201100 TABLET in 1 BOTTLE (68382-582-01) 100 tablet2021-02-010000-00-00NoNoCurrent
68382-582-10683820582101000 TABLET in 1 BOTTLE (68382-582-10) 1000 tablet2021-02-010000-00-00NoNoCurrent