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 4 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
application number: NDA018802
ndc (package): 84549-977-03
ndc (product): 84549-977
spl id: 42c6938e-f748-ae13-e063-6294a90a59a3
spl set id: 42c6938e-f747-ae13-e063-6294a90a59a3
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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