Levothyroxine Sodium

Product NDC: 70860-453
Requested package NDC: 70860-453-10
11-digit product format: 708600453
Labeler code: 70860
Product ID: 70860-453_beba3892-9b9f-4786-9ebb-b70076071295
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levothyroxine sodium anhydrous
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA208749
Marketing category: ANDA
Marketing start: 2018-12-15
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM ANHYDROUS
Active strength: 500 ug/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70860-453	70860-453-10	D	Discontinued by firm		2026-08-17

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A208749-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21
A208749-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21
A208749-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208749-001	AP
A208749-002	AP
A208749-003	AP

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 · 126 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
2026-08-18 06:07:40	2026-07	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208749-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208749-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208749-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208749-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208749-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208749-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208749-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208749-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208749-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208749-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208749-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208749-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208749-001	AP	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-453-10	2024-03-04	C162847	48780-1	1030e365-3679-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM FOR INJECTION safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM FOR INJECTION. LEVOTHYROXINE SODIUM for injection, for intravenous use Initial U.S. Approval: 1969
70860-453-10	2024-01-30	C162847	48780-1	1030e365-3679-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM FOR INJECTION safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM FOR INJECTION. LEVOTHYROXINE SODIUM for injection, for intravenous use Initial U.S. Approval: 1969

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-453-10	EA - Each	70860-453	716a81c6-b6d4-475c-a4e8-3cdda1f30f8c	1	2019-02-13

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
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Sagent Pharmaceuticals	f57e9b19-6f17-4520-80fc-511322cc56c9	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208749 application number: ANDA208749
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	MAIA Pharmaceuticals, Inc.	4e9adc35-3aba-4a0d-9c4e-7e7ee2ffdabd	2019-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208749 application number: ANDA208749

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
054I36CPMN	LEVOTHYROXINE SODIUM ANHYDROUS	55-03-8	LEVOTHYROXINE SODIUM ANHYDROUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-453-10	70860045310	1 VIAL in 1 CARTON (70860-453-10) > 5 mL in 1 VIAL	1 vial	2018-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine Sodium	Athenex Pharmaceutical Division, LLC.	2024-03-04	HUMAN PRESCRIPTION DRUG LABEL	2