Application 019893

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/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
N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019893-001	AP

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019893-001	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-12-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019893-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019893-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019893-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019893-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019893-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019893-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019893-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019893-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019893-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019893-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019893-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019893-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019893-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019893-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019893-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019893-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019893-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019893-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019893-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019893-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019893-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019893-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019893-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019893-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019893-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019893-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019893-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019893-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019893-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019893-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019893-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019893-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019893-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019893-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019893-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019893-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019893-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019893-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019893-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019893-001	AP	1	`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 MONOHYDRATE	ICU Medical Inc.	cdf35d11-fbc8-4f8e-85a8-33220312c0b4	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019893 application number: NDA019893 ndc (product): 0990-7120

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
0409-7120	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7120	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0990-7120	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7120	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7120	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7120	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current