FDA.reportPublic FDA data

NDC 68788-7697-01 - levothyroxine sodium

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
68788-7697
Requested NDC
68788-7697-01
Package NDCs from labels
68788-7697-3, 68788-7697-9, 68788-7697-1, 68788-7697-01
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2026-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
levothyroxine sodium - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2026-01-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7697-1levothyroxine sodium100 in 1 BOTTLETABLET1007
68788-7697-3levothyroxine sodium30 in 1 BOTTLETABLET307
68788-7697-9levothyroxine sodium90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7697LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240415_579b1935-77f5-4381-9cb0-e0130e4834e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7697-1EA - Each68788-7697383e850c-126a-4f04-ad7a-02719c8103bb12020-07-13
68788-7697-3EA - Each68788-7697c0409d97-4592-4717-bced-0111d6a9712112020-07-13
68788-7697-9EA - Each68788-76974c188ae3-d15c-4d74-9d33-d7e8437a000712020-07-13

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 7 of 17 · 340 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions36af0286-e447-4098-b3f2-772debd586672026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionse8142948-2bde-4f4b-931e-da43e91f2d592026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsd29bc0fd-5587-4a70-a505-f5aee1f115a62026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsd5b11dac-1acd-4aa2-b837-e3b90d4f69222026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf6c92836-95e1-1402-e053-6394a90a2f5e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionse2291336-1188-48f4-af52-d12ac892f80f2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions98d7ce2b-a248-4ed0-a2ec-d28ba623531e2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.59a99739-2da5-46a7-8811-1169123bed9b2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.579b1935-77f5-4381-9cb0-e0130e4834e82026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
ndc (package): 68788-7697-3
ndc (package): 68788-7697-9
ndc (package): 68788-7697-1
ndc (product): 68788-7697
ndc11 (package): 68788769701
rxcui: 966248
spl id: 21fcb98b-6940-4d93-86df-66ccd02b9c34
spl set id: 579b1935-77f5-4381-9cb0-e0130e4834e8
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.4e6dce46-cbf5-4353-9d0c-36b6f857197a2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMLannett Company, Inca8db0f7d-8863-9309-e053-2995a90a284a2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.3d737f79-7fc9-4221-e063-6394a90ac9aa2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCc968836a-f94c-4d13-e053-2995a90a8df52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb10e666-6204-56cc-e053-2995a90a9e082026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb5dd9d2-4f96-25d0-e053-2995a90af9dc2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCc9f4923e-5625-1d4f-e053-2a95a90aabc92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb89c58f-9dd0-b6d6-e053-2a95a90ae2e72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCd9cb3417-e8cb-13f8-e053-2a95a90a294b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCca4634a5-d8d7-48a4-e053-2995a90a0cd42026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdac0af5d-622c-e18c-e053-2995a90a57392026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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