NDC 54868-4535-2 - LEVOXYL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 54868-4535
Requested NDC: 54868-4535-2
Package NDCs from labels: 54868-4535-1, 54868-4535-2
Manufacturer: Physicians Total Care, Inc.
Effective date: 2013-08-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Levoxyl ® (levothyroxine sodium tablets, USP)	Physicians Total Care, Inc.	2013-08-19	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-4535-1	2019-09-24	C162847	48780-1	9350213a-44f6-c013-e053-90daa90a1393	Levoxyl ® (levothyroxine sodium tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-4535-1	LEVOXYL	30 in 1 BOTTLE	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-4535	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5	1 package rows	20130820_951c6e16-7251-42ed-ac19-d8367a6aee4f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-4535-0	EA - Each	54868-4535	b4aef346-caf3-4da3-8d9d-1925e154fab5	1	2012-07-24
54868-4535-1	EA - Each	54868-4535	e84f8d98-5131-4014-927f-495343aa1e72	1	2012-07-24
54868-4535-2	EA - Each	54868-4535	2dc70794-405b-4bee-8a56-d732a9fcb6e0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
CALCIUM SULFATE DIHYDRATE	INACTIVE INGREDIENT	4846Q921YM	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]	5

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 25 of 25 · 483 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM BICARBONATE	SODIUM BICARBONATE	Richmond Pharmaceuticals, Inc.	fa10d93d-b3ed-4675-a117-f573d9e72bca	2017-10-30	Warnings	Exact identifier unii: 8MDF5V39QO
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	e9698a4f-1a95-4f28-a945-e8009d1d6dd4	2017-09-27	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
05cb0c12-5291-438e-93fd-86aa7cc81611			951c6e16-7251-42ed-ac19-d8367a6aee4f	2013-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 05cb0c12-5291-438e-93fd-86aa7cc81611 spl set id: 951c6e16-7251-42ed-ac19-d8367a6aee4f

Reported adverse events (FAERS/openFDA)#

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