diluent

Generic: water solution

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diluent
Generic Name water solution
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

water 1 mL/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-6021
Product ID 0781-6021_fe80d00e-9eba-4192-9515-f9a5ad686a53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203649
Listing Expiration 2026-12-31
Marketing Start 2019-03-25

Pharmacologic Class

Established (EPC)
prostacycline vasodilator [epc]
Chemical Structure
prostaglandins i [cs]
Physiologic Effect
vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07816021
Hyphenated Format 0781-6021

Supplemental Identifiers

RxCUI
349407 349408 349409 349410
UNII
059QF0KO0R RUM6K67ESG
NUI
N0000175416 M0017817 N0000009909

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diluent (source: ndc)
Generic Name water solution (source: ndc)
Application Number ANDA203649 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mL/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0781-6021-94) / 50 mL in 1 VIAL
source: ndc

Packages (1)

0781-6021-94 1 VIAL in 1 CARTON (0781-6021-94) / 50 mL in 1 VIAL

Ingredients (1)

water (1 mL/mL)

Linked Drug Pages (1)

Treprostinil, DILUENT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "fe80d00e-9eba-4192-9515-f9a5ad686a53", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "unii": ["059QF0KO0R", "RUM6K67ESG"], "rxcui": ["349407", "349408", "349409", "349410"], "spl_set_id": ["473297ca-a872-4052-a053-87dc8f0d3c13"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Prostacycline Vasodilator [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0781-6021-94)  / 50 mL in 1 VIAL", "package_ndc": "0781-6021-94", "marketing_start_date": "20190325"}], "brand_name": "DILUENT", "product_id": "0781-6021_fe80d00e-9eba-4192-9515-f9a5ad686a53", "dosage_form": "INJECTION", "product_ndc": "0781-6021", "generic_name": "water solution", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DILUENT", "active_ingredients": [{"name": "WATER", "strength": "1 mL/mL"}], "application_number": "ANDA203649", "marketing_category": "ANDA", "marketing_start_date": "20190325", "listing_expiration_date": "20261231"}