Cytomel

Product NDC: 50090-0413
11-digit product format: 500900413
Labeler code: 50090
Product ID: 50090-0413_dba226d2-0d68-401e-a4f7-ac27410af1c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: liothyronine sodium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA010379
Marketing category: NDA
Marketing start: 1956-05-08
Marketing end: 0000-00-00
Substance: LIOTHYRONINE SODIUM
Active strength: 5 ug/1
Pharmacologic classes: l-Triiodothyronine [EPC],Triiodothyronine [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-0413		D	Discontinued by firm		2026-08-11
excluded package	package	50090-0413	50090-0413-5	D	Discontinued by firm		2026-08-11

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0413-5	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0413-5	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0413-5	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0413-5	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0413-5	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0413-5	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0413-5	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0413-5	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0413-5	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-0413-5	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0413-5	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0413-5	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0413-5	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	RLD / RS
N010379-001	CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982
N010379-002	CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982
N010379-003	CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N010379-001	AB
N010379-002	AB
N010379-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N010379-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010379-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010379-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010379-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010379-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010379-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010379-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010379-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010379-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010379-001	AB	1	`8072bd15b7f6…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Liothyronine Sodium	LIOTHYRONINE SODIUM	Mylan Pharmaceuticals Inc.	115a84c2-0126-4dd7-816e-1873875f1e49	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 010379 application number: NDA010379
Cytomel	LIOTHYRONINE SODIUM	Pfizer Laboratories Div Pfizer Inc	51452b31-ff68-4e0c-b982-c15502ebf1d3	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 010379 application number: NDA010379

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYTOMEL ® brand of liothyronine sodium tablets	A-S Medication Solutions	2017-09-27	HUMAN PRESCRIPTION DRUG LABEL	10