Application 018895

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TPN ELECTROLYTES IN PLASTIC CONTAINER	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018895-001	TPN ELECTROLYTES IN PLASTIC CONTAINER	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML	INJECTABLE / INJECTION		RLD, RS	1984-07-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N018895-001	TPN ELECTROLYTES IN PLASTIC CONTAINER	16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018895-001	TPN ELECTROLYTES IN PLASTIC CONTAINER	16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018895-001	TPN ELECTROLYTES IN PLASTIC CONTAINER	16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018895-001	TPN ELECTROLYTES IN PLASTIC CONTAINER	16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML	INJECTABLE / INJECTION	RLD, RS	1984-07-20	`a50c72e98297…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TPN Electrolytes	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUS	Hospira, Inc.	c00817bc-7b62-4abe-0280-e7930eda3f94	2026-05-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018895 application number: NDA018895 ndc (product): 0409-5779

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-5779	TPN Electrolytes	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, and SODIUM ACETATE ANHYDROUS	Hospira, Inc.	NDA	Current
0409-5779	TPN Electrolytes	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, and SODIUM ACETATE ANHYDROUS	Hospira, Inc.	NDA	Current
0409-5779	TPN Electrolytes	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, and SODIUM ACETATE ANHYDROUS	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
16085	SUPPL	2003-05-29