FDA.reportPublic FDA data

NDC 70710-1834-01 - 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
70710-1834
Requested NDC
70710-1834-01
Package NDCs from labels
70710-1834-1, 70710-1834-01
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2025-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LEVOTHYROXINE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2025-09-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1834-1LEVOTHYROXINE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
70710-1834-1LEVOTHYROXINE SODIUM5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1834LEVOTHYROXINE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, 2 package rows20241102_bf8a952c-f05b-4814-b55a-ed04be015269.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1834-1EA - Each70710-1834922da598-545c-4f6b-b02c-b0b09c060ad712025-03-04

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 1 of 1 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSONESOURCE SPECIALTY PHARMA LIMITEDae9954a5-e196-449c-abea-ebe4afbee5172026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966219
rxcui: 1115267
rxcui: 1115269
unii: 054I36CPMN
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Levothyroxine SodiumLEVOTHYROXINE SODIUMPiramal Critical Care, Inc.76139990-1355-cfb6-e053-2991aa0ace5b2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966219
rxcui: 1115267
unii: 054I36CPMN
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMZydus Pharmaceuticals USA Inc.bf8a952c-f05b-4814-b55a-ed04be0152692025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217066
ndc (package): 70710-1835-1
ndc (package): 70710-1833-1
ndc (package): 70710-1834-1
ndc (product): 70710-1833
ndc (product): 70710-1834
ndc (product): 70710-1835
ndc11 (package): 70710183401
rxcui: 966219
rxcui: 1115267
rxcui: 1115269
spl id: 2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e
spl set id: bf8a952c-f05b-4814-b55a-ed04be015269
unii: 054I36CPMN
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFosun Pharma USA Inc.3361138a-6e6f-e8df-e063-6294a90af2de2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1115267
unii: 054I36CPMN
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSENDO USA, Inc.9d815416-11c9-470e-a82f-89b0bf232e122025-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966219
rxcui: 1115267
rxcui: 1115269
unii: 054I36CPMN
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFresenius Kabi USA, LLCce990712-49c1-4f66-9ee4-c770e8ec394c2025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966219
rxcui: 1115267
rxcui: 1115269
unii: 054I36CPMN
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFresenius Kabi USA, LLC152d071f-d4aa-46d2-b397-61c1cabdd86d2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966219
rxcui: 1115267
unii: 054I36CPMN
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFresenius Kabi USA, LLCf88f44d8-2f18-4155-9d78-6323d19fbafe2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1115267
unii: 054I36CPMN
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSSagent Pharmaceuticalsf57e9b19-6f17-4520-80fc-511322cc56c92023-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966219
rxcui: 1115267
rxcui: 1115269
unii: 054I36CPMN
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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