Levothyroxine Sodium for Injection

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-10-24
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 21:16:16

Label at a glance#

ProductLEVOTHYROXINE SODIUM

Active ingredientLEVOTHYROXINE SODIUM ANHYDROUS

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1818-1

Levothyroxine Sodium for Injection

100 mcg per vial

For Intravenous Use

Discard any unused portion

Single-Dose Vial

Rx only

NDC 70771-1819-1

Levothyroxine Sodium for Injection

200 mcg per vial

For Intravenous Use

Discard any unused portion

Single-Dose Vial

Rx only

NDC 70771-1820-1

Levothyroxine Sodium for Injection

500 mcg per vial

For Intravenous Use

Discard any unused portion

Single-Dose Vial

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1115267	levothyroxine sodium 100 MCG Injection	PSN	2
1115267	levothyroxine sodium 0.1 MG Injection	SCD	2
1115267	levothyroxine sodium 100 MCG Injection	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LEVOTHYROXINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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	SPL version
70771-1818-1	LEVOTHYROXINE SODIUM	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	2
70771-1818-1	LEVOTHYROXINE SODIUM	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	5	2
70771-1819-1	LEVOTHYROXINE SODIUM	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	5	2
70771-1819-1	LEVOTHYROXINE SODIUM	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	2
70771-1820-1	LEVOTHYROXINE SODIUM	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	5	2
70771-1820-1	LEVOTHYROXINE SODIUM	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1818	LEVOTHYROXINE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, 2 package rows	20241102_f8a8dab3-3bd5-4238-b040-c42aa506ff73.zip
70771-1819	LEVOTHYROXINE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]	2	2 package rows	20241102_f8a8dab3-3bd5-4238-b040-c42aa506ff73.zip
70771-1820	LEVOTHYROXINE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]	2	2 package rows	20241102_f8a8dab3-3bd5-4238-b040-c42aa506ff73.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM ANHYDROUS
LEVOTHYROXINE
MANNITOL
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1818	70771-1818-1
70771-1819	70771-1819-1
70771-1820	70771-1820-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LEVOTHYROXINE SODIUM ANHYDROUS	054I36CPMN	ACTIB
MANNITOL	3OWL53L36A	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
LEVOTHYROXINE SODIUM ANHYDROUS	054I36CPMN	ACTIB
MANNITOL	3OWL53L36A	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
LEVOTHYROXINE SODIUM ANHYDROUS	054I36CPMN	ACTIB
MANNITOL	3OWL53L36A	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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
A217066-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24
A217066-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24
A217066-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217066-001	AP
A217066-002	AP
A217066-003	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 2 · 75 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	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217066-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217066-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217066-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2023-03-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 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	A217066-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217066-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217066-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217066-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217066-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217066-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217066-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217066-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217066-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217066-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217066-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217066-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217066-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217066-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217066-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217066-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217066-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217066-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217066-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217066-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217066-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217066-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217066-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217066-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217066-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217066-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217066-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217066-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217066-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217066-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217066-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217066-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217066-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217066-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217066-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217066-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217066-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217066-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217066-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217066-001	AP	1	`301d65b070ca…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
713d5225-2e76-463e-bcd8-9b19f63491da			f8a8dab3-3bd5-4238-b040-c42aa506ff73	2024-10-24		Exact identifier spl id: 713d5225-2e76-463e-bcd8-9b19f63491da spl set id: f8a8dab3-3bd5-4238-b040-c42aa506ff73

Reported adverse events (FAERS/openFDA)#

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