FDA.reportPublic FDA data

NDC 0409-3977-01 - EGRIFTA WR

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
0409-3977
Requested NDC
0409-3977-01
Package NDCs from labels
0409-3977-01, 0409-3977-03
Manufacturer
Theratechnologies Inc.
Effective date
2026-07-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EGRIFTA WR - Theratechnologies Inc.Theratechnologies Inc.2026-07-29HUMAN PRESCRIPTION DRUG LABEL
Bacteriostatic Water - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-05-22HUMAN PRESCRIPTION DRUG LABEL
Bacteriostatic Water - ProPharma DistributionProPharma Distribution2025-11-04HUMAN PRESCRIPTION DRUG LABEL
Bacteriostatic Water Injection, USP 30 mL Multi Dose VialHenry Schein, Inc.2025-10-27HUMAN PRESCRIPTION DRUG LABEL
BACTERIOSTATIC WATER - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2025-01-08HUMAN PRESCRIPTION DRUG LABEL
BACTERIOSTATIC WATER Rx only for Injection, USPREMEDYREPACK INC.2024-02-15HUMAN PRESCRIPTION DRUG LABEL
Bacteriostatic Water - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-22HUMAN PRESCRIPTION DRUG LABEL
Bacteriostatic Water - General Injectables & Vaccine, IncGeneral Injectables & Vaccine, Inc2022-12-27HUMAN PRESCRIPTION DRUG LABEL
Bacteriostatic Water - US MedSource, LLCUS MedSource, LLC2014-07-07Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3977-01Bacteriostatic Water30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3019
0409-3977-03Bacteriostatic Water25 in 1 TRAYINJECTION, SOLUTION2519

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3977BACTERIOSTATIC WATER INJECTION, SOLUTION [HOSPIRA, INC.]19Current NDC, Legacy NDC, 2 package rows20241207_87d6e9dc-fe3b-4593-ac9a-d7493d1959c7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3977-01ML - Milliliter0409-3977dc4783b8-78a0-49ff-a186-538a967f090f12015-04-03
0409-3977-03ML - Milliliter0409-39772235b13d-bd7c-4158-8541-eddee9e9063112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WaterACTIVE INGREDIENT059QF0KO0RBACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINE, INC]2
WaterACTIVE MOIETY059QF0KO0RBACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINE, INC]2
WATERACTIVE INGREDIENT059QF0KO0RBACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
WATERACTIVE MOIETY059QF0KO0RBACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHBACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION [US MEDSOURCE, LLC]1

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 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA018802
ndc (package): 0404-9970-30
ndc (product): 0404-9970
spl id: 020852cf-7148-4456-a0ce-d9845d7c3fe3
spl set id: a833502e-a622-4e81-8c58-cef6ccb6c4c9
unii: 059QF0KO0R
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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