FDA.reportPublic FDA data

NDC 63629-8712-01 - 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
63629-8712
Requested NDC
63629-8712-01
Package NDCs from labels
63629-8712-1, 63629-8712-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
levothyroxine sodium - Bryant Ranch PrepackBryant Ranch Prepack2024-08-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8712-1levothyroxine sodium1000 in 1 BOTTLETABLET1000105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8712LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240807_c22af2e0-fb36-4645-a911-3d293af5bd88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8712-1EA - Each63629-871253344a25-cf37-41b6-a671-b103d27e912312021-10-08

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 2 of 18 · 341 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack3b282e57-1009-4d2c-8ca2-9cca9f7919372026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC53e84179-fe2a-5696-e063-6394a90a85662026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMCoupler LLC5383a4d8-319a-5bf6-e063-6294a90a54972026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNCS HealthCare of KY, LLC dba Vangard Labsabe173cc-1579-43a5-b12d-a31958d0a5392026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCardinal Health 107, LLC66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC53316e75-9897-4935-e063-6294a90a94cf2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack5852d874-1ebc-49ff-b6c2-1dd513fca7842026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
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
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC52cd19e4-a4b3-ecee-e063-6394a90ac33b2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackdb5cba81-9ad5-42ad-ac9e-a967337630f22026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd9ccea69-109d-44cf-927b-4ff67652b6a02026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.4f40db1e-3dd9-4c7b-93e6-64f0fd10d5512026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack50978a14-fd72-4c76-927f-667a1f097b872026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.eb53dc23-8337-497e-b466-192f905563ed2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.6d65b528-f52b-4b5d-8b76-46fbd4576f992026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.3519c765-2077-4f23-8644-a6242ddbf7432026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.c38c3c31-6834-4590-ace0-f525e5599f662026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.ac10b751-5195-4987-a841-400ae79730f02026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021116
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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