LEVO-T

Product NDC: 55466-111
11-digit product format: 554660111
Labeler code: 55466
Product ID: 55466-111_87ec4603-08d5-2e32-e053-2a95a90ab8ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Neolpharma, Inc.
Application: NDA021342
Marketing category: NDA
Marketing start: 2015-10-29
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM
Active strength: 137 ug/1
Pharmacologic classes: l-Thyroxine [EPC],Thyroxine [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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55466-111		D	Discontinued by firm		2026-10-15
excluded package	package	55466-111	55466-111-11	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N021342-001	LEVO-T	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-002	LEVO-T	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-003	LEVO-T	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-004	LEVO-T	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-005	LEVO-T	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-006	LEVO-T	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-007	LEVO-T	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-008	LEVO-T	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-009	LEVO-T	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-010	LEVO-T	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-011	LEVO-T	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-012	LEVO-T	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 36 matching rows.

Application-product, TE code table
Application-product	TE code
N021342-001	AB1
N021342-001	AB2
N021342-001	AB3
N021342-002	AB1
N021342-002	AB2
N021342-002	AB3
N021342-003	AB1
N021342-003	AB2
N021342-003	AB3
N021342-004	AB1
N021342-004	AB2
N021342-004	AB3
N021342-005	AB1
N021342-005	AB2
N021342-005	AB3
N021342-006	AB1
N021342-006	AB2
N021342-006	AB3
N021342-007	AB1
N021342-007	AB2
N021342-007	AB3
N021342-008	AB1
N021342-008	AB2
N021342-008	AB3
N021342-009	AB1
N021342-009	AB2
N021342-009	AB3
N021342-010	AB1
N021342-010	AB2
N021342-010	AB3
N021342-011	AB1
N021342-011	AB2
N021342-011	AB3
N021342-012	AB1
N021342-012	AB2
N021342-012	AB3

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 14 · 528 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
2026-10-15 13:18:30	2026-09	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 40 · 1,584 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021342-001	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-001	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-001	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-002	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-002	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-002	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-003	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-003	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-003	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-004	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-004	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-004	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-005	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-005	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-005	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-006	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-006	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-006	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-007	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-007	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-007	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-008	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-008	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-008	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-009	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-009	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-009	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-010	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-010	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-010	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-011	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-011	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-011	AB3	3	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-012	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-012	AB2	2	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021342-012	AB3	3	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021342-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-002	AB1	1	`84e616aacf4f…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021342-001	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-002	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-003	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-004	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-005	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-006	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-007	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-008	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-009	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-010	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-011	6399101	2020-03-30	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021342-001	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-002	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-003	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-004	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-005	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-006	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-007	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-008	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-009	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-010	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-011	6399101	2020-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021342-001	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-002	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-003	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-004	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-005	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-006	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-007	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-008	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-009	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-010	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-011	6399101	2020-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021342-001	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-002	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-003	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-004	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-005	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-006	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-007	6399101	2020-03-30	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003	Product name	3	20240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8	Product name	5	20240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9f	Product name	5	20240207
01383843-4069-43cf-aa76-dc17a6f9f8c4	Product name	2	20230123
978cca7d-a938-4791-8322-da48d90a63ef	Product name	1	20230113
65f86ba3-8816-4e12-899b-18290c8de551	Product name	2	20210614
f16ab90f-08c2-40be-a543-66d9827cd1f3	Product name	1	20210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55466-111-11	LEVO-T	90 in 1 BOTTLE	TABLET	90		18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]	1
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55466-111	LEVO-T (LEVOTHYROXINE SODIUM) TABLET [NEOLPHARMA, INC.]	18	Legacy NDC, 1 package rows	20240420_2085385a-7fe4-5bfe-e054-00144ff88e88.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 3 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	b1b8c5a4-8132-24d2-e053-2995a90a59ec	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	56c633a9-3f64-46bd-b93f-afbff92b5559	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	e1b322a6-9161-45b9-bf77-3c44502d5efd	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	e486f83b-6cf0-4e7d-99ed-cfd19c4501e1	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d6ce9798-7204-41df-9aeb-067000cb0895	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	59762069-5ea7-43d9-ba5b-8b250767b146	2023-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	ca197216-83f1-470a-9313-d1b923924661	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	7ceed5ff-fd41-4ebd-ade7-e31b135231c1	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	LEVOTHYROXINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966178	Levo-T 100 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966397	Levo-T 112 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966188	Levo-T 125 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966410	Levo-T 137 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966197	Levo-T 150 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966399	Levo-T 175 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966208	Levo-T 200 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966154	Levo-T 25 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966214	Levo-T 300 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966161	Levo-T 50 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966167	Levo-T 75 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966401	Levo-T 88 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966154	levothyroxine sodium 0.025 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966161	levothyroxine sodium 0.05 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966167	levothyroxine sodium 0.075 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966401	levothyroxine sodium 0.088 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966178	levothyroxine sodium 0.1 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966397	levothyroxine sodium 0.112 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966188	levothyroxine sodium 0.125 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966410	levothyroxine sodium 0.137 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966197	levothyroxine sodium 0.15 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966399	levothyroxine sodium 0.175 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966208	levothyroxine sodium 0.2 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966214	levothyroxine sodium 0.3 MG Oral Tablet [Levo-T]	SBD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
892255	levothyroxine sodium 0.3 MG Oral Tablet	SCD	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966154	Levo-T 0.025 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966161	Levo-T 0.05 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966167	Levo-T 0.075 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966401	Levo-T 0.088 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966178	Levo-T 0.1 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966397	Levo-T 0.112 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966188	Levo-T 0.125 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966410	Levo-T 0.137 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966197	Levo-T 0.15 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966399	Levo-T 0.175 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966208	Levo-T 0.2 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966214	Levo-T 0.3 MG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966178	Levo-T 100 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966397	Levo-T 112 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966188	Levo-T 125 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966410	Levo-T 137 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966197	Levo-T 150 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966399	Levo-T 175 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966208	Levo-T 200 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966154	Levo-T 25 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966214	Levo-T 300 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966161	Levo-T 50 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966167	Levo-T 75 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966401	Levo-T 88 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	2085385a-7fe4-5bfe-e054-00144ff88e88	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55466-111-11	55466011111	90 TABLET in 1 BOTTLE (55466-111-11)	90 tablet	2015-10-29	0000-00-00	No	No	Current