FDA.reportPublic FDA data

TM Biowater

Product NDC
87597-003
11-digit product format
875970003
Labeler code
87597
Product ID
87597-003_51b5314c-3260-5b55-e063-6294a90acec7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacteriostatic Water
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
TM BIOWATER
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-05-12
Substance
BENZYL ALCOHOL
Active strength
.9 mg/mL
Pharmacologic classes
Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct87597-003DDiscontinued by firm2026-08-17
excluded packagepackage87597-00387597-003-30DDiscontinued by firm2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87597-003-30TM Biowater30 mL in 1 VIAL, MULTI-DOSEINJECTION303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87597-003-308759700033030 mL in 1 VIAL, MULTI-DOSE (87597-003-30) 30 ml2026-05-12NoNoHistorical