Application 017608

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	Yes	No

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
N017608-001	DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017608-001	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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017608-001	DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017608-001	DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017608-001	DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017608-001	DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017608-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017608-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017608-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017608-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017608-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017608-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017608-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017608-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017608-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017608-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017608-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017608-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017608-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017608-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017608-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017608-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017608-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017608-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017608-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017608-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017608-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017608-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017608-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017608-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017608-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017608-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017608-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017608-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017608-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017608-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017608-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017608-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017608-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017608-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017608-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017608-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017608-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017608-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017608-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017608-001	AP	1	`3a93d1ddd44b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	d310d170-5eeb-471b-af1a-0e845001d21d	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017608 application number: NDA017608 ndc (product): 0990-7929
LACTATED RINGERS AND DEXTROSE	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	a62cf623-9b8a-37e0-e053-2995a90add5b	2020-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017608 application number: NDA017608 ndc (product): 51662-1521

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0990-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
51662-1229	LACTATED RINGERS AND DEXTROSE	SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1229	LACTATED RINGERS AND DEXTROSE	SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1229	LACTATED RINGERS AND DEXTROSE	SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1521	LACTATED RINGERS AND DEXTROSE	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current