Liothyronine Sodium

Product NDC
39822-0151
11-digit product format
398220151
Labeler code
39822
Product ID
39822-0151_02f79412-2198-a8af-e063-6394a90a0853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Liothyronine Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA076923
Marketing category
ANDA
Marketing start
2005-08-17
Substance
LIOTHYRONINE SODIUM
Active strength
10 ug/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076923-001LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-173f01610625f2…
2019-09-15 20:21 UTC2019-09A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONRS2005-08-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076923-001LIOTHYRONINE SODIUMEQ 0.01MG BASE/MLINJECTABLE / INJECTIONAP2005-08-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076923-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076923-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076923-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076923-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076923-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076923-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076923-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A076923-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076923-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076923-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076923-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A076923-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076923-001AP1ea99ee380514…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076923-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076923-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076923-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076923-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076923-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076923-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076923-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIOTHYRONINE SODIUM10 ug/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
903694Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8b39730-de19-497d-bde8-6594aa528403Available 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
39822-0151-1Liothyronine Sodium1 mL in 1 VIALINJECTION, SOLUTION117
39822-0151-1Liothyronine Sodium1 in 1 CARTONINJECTION, SOLUTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0151-1ML - Milliliter39822-0151f5bea33f-670c-4720-ad4f-de4bf7ff577212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0151LIOTHYRONINE SODIUM INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]17Current NDC, Legacy NDC, 2 package rows20231108_a8b39730-de19-497d-bde8-6594aa528403.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liothyronine SodiumLIOTHYRONINE SODIUMXGen Pharmaceuticals DJB, Inc.a8b39730-de19-497d-bde8-6594aa5284032023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076923
application number: ANDA076923
ndc (product): 39822-0151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903694liothyronine sodium 10 MCG in 1 ML InjectionPSNa8b39730-de19-497d-bde8-6594aa52840317
9036941 ML liothyronine sodium 0.01 MG/ML InjectionSCDa8b39730-de19-497d-bde8-6594aa52840317
903694liothyronine sodium 0.01 MG per 1 ML InjectionSYa8b39730-de19-497d-bde8-6594aa52840317
903694liothyronine sodium 10 MCG per 1 ML InjectionSYa8b39730-de19-497d-bde8-6594aa52840317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0151-1398220151011 VIAL in 1 CARTON (39822-0151-1) / 1 mL in 1 VIAL1 vial2005-08-170000-00-00NoNoCurrent