Levothyroxine Sodium

Product NDC: 66794-648
11-digit product format: 667940648
Labeler code: 66794
Product ID: 66794-648_9a6e827d-7556-4de8-e053-2a95a90a0777
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Piramal Critical Care, Inc.
Application: NDA202231
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-06-15
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	66794-648		D	Discontinued by firm		2026-07-31
excluded package	package	66794-648	66794-648-02	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202231-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24
N202231-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24
N202231-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202231-001	AP
N202231-002	AP
N202231-003	AP

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N202231-001	9168238	2032-08-29	Drug product	2015-10-28
N202231-001	9168239	2032-08-29	Drug product	2015-10-28
N202231-001	9006289	2032-10-03	Drug product	2015-04-14
N202231-002	9168238	2032-08-29	Drug product	2015-10-28
N202231-002	9168239	2032-08-29	Drug product	2015-10-28
N202231-002	9006289	2032-10-03	Drug product	2015-04-14
N202231-003	9168238	2032-08-29	Drug product	2015-10-28
N202231-003	9168239	2032-08-29	Drug product	2015-10-28
N202231-003	9006289	2032-10-03	Drug product	2015-04-14

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N202231-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-002	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-003	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N202231-001	9168238	2032-08-29	Drug product	2015-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-001	9168239	2032-08-29	Drug product	2015-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-001	9006289	2032-10-03	Drug product	2015-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-002	9168238	2032-08-29	Drug product	2015-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-002	9168239	2032-08-29	Drug product	2015-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-002	9006289	2032-10-03	Drug product	2015-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-003	9168238	2032-08-29	Drug product	2015-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-003	9168239	2032-08-29	Drug product	2015-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202231-003	9006289	2032-10-03	Drug product	2015-04-14	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	ENDO USA, Inc.	9d815416-11c9-470e-a82f-89b0bf232e12	2025-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202231 application number: NDA202231
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	ce990712-49c1-4f66-9ee4-c770e8ec394c	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202231 application number: NDA202231
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	152d071f-d4aa-46d2-b397-61c1cabdd86d	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202231 application number: NDA202231
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	f88f44d8-2f18-4155-9d78-6323d19fbafe	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202231 application number: NDA202231

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66794-648-02	EA - Each	66794-648	efd0037b-8536-45df-a210-44f3a627e3cd	1	2018-07-03

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
054I36CPMN	LEVOTHYROXINE SODIUM ANHYDROUS	55-03-8	LEVOTHYROXINE SODIUM ANHYDROUS
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	Levothyroxine Sodium

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine Sodium	Piramal Critical Care, Inc. \| Fresenius Kabi, LLC	2019-12-24	HUMAN PRESCRIPTION DRUG LABEL	3