Liothyronine sodium

Product NDC: 68382-584
11-digit product format: 683820584
Labeler code: 68382
Product ID: 68382-584_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: 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214803-001	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22
A214803-002	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22
A214803-003	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214803-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214803-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214803-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214803-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214803-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214803-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214803-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214803-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214803-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214803-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIOTHYRONINE SODIUM	50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GCA9VV7D2N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c54cf95f-6465-4203-b98b-a54ba5a26843	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b42496cd-a994-8ba1-597f-e507aa62246e	Product name	5	20250116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68382-584-01	Liothyronine sodium	100 in 1 BOTTLE	TABLET	100		4
68382-584-10	Liothyronine sodium	1000 in 1 BOTTLE	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-584-01	EA - Each	68382-584	a15d0e37-7037-4aaf-9698-03a785502214	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-584	LIOTHYRONINE SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240814_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Liothyronine sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	b18e24fd-def0-4ff4-aa08-5f91c03c6f9e	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803
Liothyronine sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	5222f13d-7222-4845-b863-49e7558f5b1a	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803
Liothyronine sodium	LIOTHYRONINE SODIUM	Zydus Pharmaceuticals (USA) Inc.	c54cf95f-6465-4203-b98b-a54ba5a26843	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803 ndc (product): 68382-584
Liothyronine sodium	LIOTHYRONINE SODIUM	Northstar Rx LLC	c97dc9ec-af73-4836-aa0d-c27e66e792a9	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803
Liothyronine sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	9d3633e3-44b7-4f62-9fe4-e5c7c4129345	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803
Liothyronine sodium	LIOTHYRONINE SODIUM	Zydus Lifesciences Limited	4fb09346-3d30-4a7c-a97c-480d5924997a	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803
Liothyronine sodium	LIOTHYRONINE SODIUM	A-S Medication Solutions	52baac91-4b00-40d4-9ca7-8b9405bd415c	2023-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GCA9VV7D2N	LIOTHYRONINE SODIUM	55-06-1	LIOTHYRONINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
903703	liothyronine sodium 50 MCG Oral Tablet	PSN	9d3633e3-44b7-4f62-9fe4-e5c7c4129345	103
903703	liothyronine sodium 0.05 MG Oral Tablet	SCD	9d3633e3-44b7-4f62-9fe4-e5c7c4129345	103
903703	liothyronine sodium 50 MCG Oral Tablet	SY	9d3633e3-44b7-4f62-9fe4-e5c7c4129345	103
903697	liothyronine sodium 25 MCG Oral Tablet	PSN	c54cf95f-6465-4203-b98b-a54ba5a26843	4
903456	liothyronine sodium 5 MCG Oral Tablet	PSN	c54cf95f-6465-4203-b98b-a54ba5a26843	4
903703	liothyronine sodium 50 MCG Oral Tablet	PSN	c54cf95f-6465-4203-b98b-a54ba5a26843	4
903456	liothyronine sodium 0.005 MG Oral Tablet	SCD	c54cf95f-6465-4203-b98b-a54ba5a26843	4
903697	liothyronine sodium 0.025 MG Oral Tablet	SCD	c54cf95f-6465-4203-b98b-a54ba5a26843	4
903703	liothyronine sodium 0.05 MG Oral Tablet	SCD	c54cf95f-6465-4203-b98b-a54ba5a26843	4
903697	liothyronine sodium 25 MCG Oral Tablet	SY	c54cf95f-6465-4203-b98b-a54ba5a26843	4
903456	liothyronine sodium 5 MCG Oral Tablet	SY	c54cf95f-6465-4203-b98b-a54ba5a26843	4
903703	liothyronine sodium 50 MCG Oral Tablet	SY	c54cf95f-6465-4203-b98b-a54ba5a26843	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-584-01	68382058401	100 TABLET in 1 BOTTLE (68382-584-01)	100 tablet	2021-02-01	0000-00-00	No	No	Current
68382-584-10	68382058410	1000 TABLET in 1 BOTTLE (68382-584-10)	1000 tablet	2021-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Liothyronine sodium	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	103
Liothyronine sodium	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Global FZE \| Zydus Lifesciences Limited	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	4