NDC 52584-887

Sterile Water

Water

Sterile Water is a Intramuscular; Intravenous; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Water.

• Product ID: 52584-887_1983177f-9d92-463b-bb0e-068682a710aa
• NDC: 52584-887
• Product Type: Human Prescription Drug
• Proprietary Name: Sterile Water
• Generic Name: Water
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2010-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA018801
• Labeler Name: General Injectables & Vaccines, Inc
• Substance Name: WATER
• Active Ingredient Strength: 1 mL/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 52584-887-10

1 VIAL, SINGLE-DOSE in 1 BAG (52584-887-10) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2016-07-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-887-50 [52584088750]

Sterile Water INJECTION

• Marketing Category: NDA
• Application Number: NDA018801
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-20
• Marketing End Date: 2021-07-01

NDC 52584-887-99 [52584088799]

Sterile Water INJECTION

• Marketing Category: NDA
• Application Number: NDA018801
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-20
• Marketing End Date: 2017-01-18

NDC 52584-887-20 [52584088720]

Sterile Water INJECTION

• Marketing Category: NDA
• Application Number: NDA018801
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-20
• Marketing End Date: 2021-07-01

NDC 52584-887-10 [52584088710]

Sterile Water INJECTION

• Marketing Category: NDA
• Application Number: NDA018801
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-20
• Marketing End Date: 2021-07-01

Drug Details

Active Ingredients

Ingredient	Strength
WATER	1 mL/mL

OpenFDA Data

• SPL SET ID: c6eed2ad-25f3-479e-9c28-1945eea88f8d
• Manufacturer:
  • General Injectables & Vaccines, Inc
• UNII:
  • 059QF0KO0R
• RxNorm Concept Unique ID - RxCUI:
  • 540930

NDC Crossover Matching brand name "Sterile Water" or generic name "Water"

NDC	Brand Name	Generic Name
0264-2101	Sterile Water	Water
0264-7385	Sterile Water	Water
0264-7386	Sterile Water	Sterile Water
0264-7850	Sterile Water	Water
0338-0003	Sterile Water	Water
0338-0004	Sterile Water	Water
0338-0013	Sterile Water	Water
0409-4887	Sterile Water	Sterile Water
0409-6139	Sterile Water	Sterile Water
0409-7118	Sterile Water	Sterile Water
0409-7139	Sterile Water	Sterile Water
0409-7973	Sterile Water	Sterile Water
0409-7990	Sterile Water	Sterile Water
0517-3005	Sterile Water	Sterile Water
0517-3020	Sterile Water	Sterile Water
0517-3010	Sterile Water	Sterile Water
71872-7041	Sterile Water	Sterile Water
0641-6147	Sterile Water	Sterile Water
50090-2874	Sterile Water	Sterile Water
50242-001	Sterile Water	Sterile Water
51662-1329	STERILE WATER	STERILE WATER
51662-1265	STERILE WATER	STERILE WATER
51662-1266	STERILE WATER	STERILE WATER
52584-079	STERILE WATER	STERILE WATER
52584-887	Sterile Water	Sterile Water
55154-0127	Sterile Water	Sterile Water
55154-2379	Sterile Water	Sterile Water
63323-178	Sterile Water	Sterile Water
63323-185	Sterile Water	Sterile Water
64725-4887	Sterile Water	Sterile Water
0990-7118	Sterile Water	Sterile Water
52584-147	Sterile Water	Sterile Water
0990-7973	Sterile Water	Sterile Water
0990-6139	Sterile Water	Sterile Water
0990-7139	Sterile Water	Sterile Water
0990-7990	Sterile Water	Sterile Water
0173-0518	Diluent	water
0173-0857	Diluent	water
0404-7198	Eyewash	Water
0006-4309	STERILE DILUENT	Sterile Water