Application 019345

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 30% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	30GM/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	DEXTROSE	30GM/100ML	INJECTABLE / INJECTION		RLD, RS	1985-01-26

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019345-001	DEXTROSE 30% IN PLASTIC CONTAINER	30GM/100ML	INJECTABLE / INJECTION	RLD, RS	1985-01-26	`e64feba35796…`

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
Dextrose	DEXTROSE	ICU Medical Inc.	b5cb7a5a-bbe8-4217-a82e-da818f7771c9	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019345 application number: NDA019345 ndc (product): 0990-8004

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-8004	Dextrose	dextrose	Hospira, Inc.	NDA	Current
0409-8004	Dextrose	dextrose	Hospira, Inc.	NDA	Current
0990-8004	Dextrose	dextrose	ICU Medical Inc.	NDA	Current
0990-8004	Dextrose	dextrose	ICU Medical Inc.	NDA	Current
0990-8004	Dextrose	dextrose	ICU Medical Inc.	NDA	Current
0990-8004	Dextrose	dextrose	ICU Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54242	SUPPL	2018-05-17
54209	SUPPL	2018-05-16
1289	SUPPL	2016-02-24
33727	SUPPL	2016-02-23