Liothyronine Sodium

Product NDC
51862-321
11-digit product format
518620321
Labeler code
51862
Product ID
51862-321_be3f7994-e226-4c95-9749-2c33a95e2da8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liothyronine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma
Application
ANDA090097
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
LIOTHYRONINE SODIUM
Active strength
25 ug/1
Pharmacologic classes
l-Triiodothyronine [EPC],Triiodothyronine [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51862-321DDiscontinued by firm2026-08-03
excluded packagepackage51862-32151862-321-01DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-321-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-321-01f5e01cc5f278…a2eaf40c39c3…

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
A090097-001LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-20
A090097-002LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-20
A090097-003LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090097-001AB
A090097-002AB
A090097-003AB

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 UTC2026-02A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090097-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2009-03-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090097-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALAB2009-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090097-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2009-03-208072bd15b7f6…

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 UTC2026-02A090097-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090097-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090097-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090097-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090097-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090097-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090097-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090097-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090097-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090097-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090097-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090097-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090097-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090097-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090097-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090097-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090097-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090097-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090097-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090097-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090097-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090097-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090097-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090097-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090097-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090097-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090097-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090097-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090097-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090097-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090097-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090097-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090097-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090097-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090097-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090097-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090097-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090097-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090097-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090097-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b42496cd-a994-8ba1-597f-e507aa62246eProduct name520250116
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-321-01EA - Each51862-321eadec44f-831b-4a74-877b-e81faeb2102c12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-321LIOTHYRONINE SODIUM TABLET [MAYNE PHARMA COMMERCIAL LLC]3Legacy NDC20230707_03ca9e2a-5a27-43ff-a1cd-9c617a415b62.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liothyronine SodiumLIOTHYRONINE SODIUMGolden State Medical Supply, Inc.ababc2ad-0458-663e-e053-2a95a90a5a862025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090097
application number: ANDA090097
Liothyronine SodiumLIOTHYRONINE SODIUMDr. Reddy's Labratories Inc.0b0f2db9-642d-d84f-b102-b43de34bbe752024-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090097
application number: ANDA090097

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903697liothyronine sodium 25 MCG Oral TabletPSNababc2ad-0458-663e-e053-2a95a90a5a866
903456liothyronine sodium 5 MCG Oral TabletPSNababc2ad-0458-663e-e053-2a95a90a5a866
903703liothyronine sodium 50 MCG Oral TabletPSNababc2ad-0458-663e-e053-2a95a90a5a866
903456liothyronine sodium 0.005 MG Oral TabletSCDababc2ad-0458-663e-e053-2a95a90a5a866
903697liothyronine sodium 0.025 MG Oral TabletSCDababc2ad-0458-663e-e053-2a95a90a5a866
903703liothyronine sodium 0.05 MG Oral TabletSCDababc2ad-0458-663e-e053-2a95a90a5a866
903697liothyronine sodium 25 MCG Oral TabletSYababc2ad-0458-663e-e053-2a95a90a5a866
903456liothyronine sodium 5 MCG Oral TabletSYababc2ad-0458-663e-e053-2a95a90a5a866
903703liothyronine sodium 50 MCG Oral TabletSYababc2ad-0458-663e-e053-2a95a90a5a866

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-321-0151862032101100 TABLET in 1 BOTTLE, PLASTIC (51862-321-01) 100 tablet2018-01-010000-00-00NoNoCurrent