FDA.reportPublic FDA data

NDC 69238-1840-01 - 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
69238-1840
Requested NDC
69238-1840-01
Package NDCs from labels
69238-1840-1, 69238-1840-7, 69238-1840-01
Manufacturer
Amneal Pharmaceuticals NY LLC
Effective date
2024-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levothyroxine Sodium - Amneal Pharmaceuticals NY LLCAmneal Pharmaceuticals NY LLC2024-12-06HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - Bryant Ranch PrepackBryant Ranch Prepack2020-09-20HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine Sodium - A-S Medication SolutionsA-S Medication Solutions2019-02-21HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69238-1840-12024-02-08Levothyroxine Sodium Tablets, USP
69238-1840-72024-02-08Levothyroxine Sodium Tablets, USP
69238-1840-12024-01-30Levothyroxine Sodium Tablets, USP
69238-1840-72024-01-30Levothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1840-1Levothyroxine Sodium100 in 1 BOTTLE, PLASTICTABLET10010
69238-1840-7Levothyroxine Sodium1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1840LEVOTHYROXINE SODIUM TABLET [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 2 package rows20241208_fca88c97-5cd4-4834-ba87-deb5bd637788.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1840-1EA - Each69238-18401a39d8a8-91fd-496d-934b-2e5f516d9bb812018-12-13
69238-1840-7EA - Each69238-184073d69f86-4bb7-434d-8659-bdbf2a192b0712018-12-13

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 5 of 48 · 952 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsc8ae9dc4-836f-4912-80d7-684fd374f40a2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC52cce695-4363-8a2c-e063-6294a90a1bbf2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC52cd19e4-a4b3-ecee-e063-6394a90ac33b2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966225
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackdb5cba81-9ad5-42ad-ac9e-a967337630f22026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966270
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd9ccea69-109d-44cf-927b-4ff67652b6a02026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.4f40db1e-3dd9-4c7b-93e6-64f0fd10d5512026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966225
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack50978a14-fd72-4c76-927f-667a1f097b872026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.eb53dc23-8337-497e-b466-192f905563ed2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.6d65b528-f52b-4b5d-8b76-46fbd4576f992026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966270
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.3519c765-2077-4f23-8644-a6242ddbf7432026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.c38c3c31-6834-4590-ace0-f525e5599f662026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.ac10b751-5195-4987-a841-400ae79730f02026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.83854522-f22e-491f-8392-c8b1f94417602026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 966224
rxcui: 966253
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.645c52bb-c46e-426e-91d4-151aeac975a72026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.65c8b305-8ffb-4aa5-aca1-f4e4ead71a9c2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.633b3f9c-9578-4e07-a515-aec1a8b65e922026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.0cffbc96-7a02-4538-9966-b69249be6eb22026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepacke293dd94-b523-47a2-8bed-e6d99945ee592026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack776c8dbc-ca34-40f9-9730-4aa59f6447032026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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