Levothyroxine Sodium

Product NDC: 0527-3288
11-digit product format: 005273288
Labeler code: 0527
Product ID: 0527-3288_47e50f93-a701-747e-e063-6294a90a5259
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc
Application: NDA021342
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-08-03
Substance: LEVOTHYROXINE SODIUM
Active strength: 150 ug/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 13 · 516 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
2026-09-14 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…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 39 · 1,548 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2026-09-14 22:38:34	2026-08	N021342-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-011	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-012	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-012	AB3	3	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021342-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-001	AB3	3	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-002	AB1	1	`caaa826d4ba7…`

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Levothyroxine Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	150 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9J765S329G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892246	Internal RxNorm lookup
892251	Internal RxNorm lookup
892255	Internal RxNorm lookup
966220	Internal RxNorm lookup
966221	Internal RxNorm lookup
966222	Internal RxNorm lookup
966224	Internal RxNorm lookup
966225	Internal RxNorm lookup
966248	Internal RxNorm lookup
966249	Internal RxNorm lookup
966253	Internal RxNorm lookup
966270	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
a8db0f7d-8863-9309-e053-2995a90a284a	Available on FDA.report

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
0527-3288-43	Levothyroxine Sodium	1000 in 1 BOTTLE	TABLET	1000		4
0527-3288-46	Levothyroxine Sodium	90 in 1 BOTTLE	TABLET	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-3288-43	EA - Each	0527-3288	6ba0ae6b-1f66-4e0f-ae44-332a2ddfc250	1	2020-08-06
0527-3288-46	EA - Each	0527-3288	88d07da7-5821-4f45-9cb3-aa39ee600f34	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-3288	LEVOTHYROXINE SODIUM TABLET [LANNETT COMPANY, INC]	3	Current NDC, Legacy NDC, 2 package rows	20240103_a8db0f7d-8863-9309-e053-2995a90a284a.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 2 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	Bryant Ranch Prepack	66bb0ba9-cd63-4817-907f-7b8ad5dc6685	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	8ac112c3-1e06-4fdb-a7af-2ee988de5b15	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	69fb5cd6-90ba-487d-a754-07c664a1fdd1	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f6c92836-95e1-1402-e053-6394a90a2f5e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Lannett Company, Inc	a8db0f7d-8863-9309-e053-2995a90a284a	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342 ndc (product): 0527-3288
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31b5d54-7536-4290-e053-2a95a90ac235	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f32b4a01-edea-fc85-e053-2995a90ac175	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31a35cb-fc54-8872-e053-2a95a90ad8e7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31ba297-e042-187a-e053-2a95a90a4861	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31d987d-6836-b4a7-e053-2a95a90a8f7b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86e74e1-0d55-8d0e-e053-6394a90a07bf	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86efc89-f784-c8bb-e053-6294a90a63c9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db9821db-3fe3-d1cf-e053-2a95a90a0252	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86fab39-bbd9-a51c-e053-6294a90accd0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	472ec9e7-c1db-bf8c-e063-6394a90a2c07	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	4302e36f-0b5b-f645-e063-6394a90a010f	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	9e588c43-b9b5-478e-99f7-e197add3cd26	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	91afb351-f067-49a2-bdf0-336ea209718d	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	237cc591-c40b-416f-ac00-96cd61bc59dc	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	8f83fd60-5aa7-4e7f-a6e9-917e2c1abf27	2024-08-21	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
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	e486f83b-6cf0-4e7d-99ed-cfd19c4501e1	103
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	e486f83b-6cf0-4e7d-99ed-cfd19c4501e1	103
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	e486f83b-6cf0-4e7d-99ed-cfd19c4501e1	103
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	5c1cf991-6177-499d-a9b8-63e5ca92eb79	102
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	5c1cf991-6177-499d-a9b8-63e5ca92eb79	102
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	5c1cf991-6177-499d-a9b8-63e5ca92eb79	102
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	f86efc89-f784-c8bb-e053-6294a90a63c9	6
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	f86efc89-f784-c8bb-e053-6294a90a63c9	6
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	f86efc89-f784-c8bb-e053-6294a90a63c9	6
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	a8db0f7d-8863-9309-e053-2995a90a284a	4
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
892255	levothyroxine sodium 0.3 MG Oral Tablet	SCD	a8db0f7d-8863-9309-e053-2995a90a284a	4
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
892255	levothyroxine sodium 300 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	a8db0f7d-8863-9309-e053-2995a90a284a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-3288-43	00527328843	1000 TABLET in 1 BOTTLE (0527-3288-43)	1000 tablet	2020-08-03	0000-00-00	No	No	Current
0527-3288-46	00527328846	90 TABLET in 1 BOTTLE (0527-3288-46)	90 tablet	2020-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine Sodium	Bryant Ranch Prepack	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	102
Levothyroxine Sodium	Lannett Company, Inc \| Neolpharma, Inc.	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	4
Levothyroxine Sodium	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	6
Levothyroxine Sodium	Bryant Ranch Prepack	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL	103
Levothyroxine Sodium	A-S Medication Solutions	2021-09-16	HUMAN PRESCRIPTION DRUG LABEL	1