Application 018494

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;IRRIGATION	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	No	No

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
N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT		1982-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018494-001	AT

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018494-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	1982-02-19	`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	N018494-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018494-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018494-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018494-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018494-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018494-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018494-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018494-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018494-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018494-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018494-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018494-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018494-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018494-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018494-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018494-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018494-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018494-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018494-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018494-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018494-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018494-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018494-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018494-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018494-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018494-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018494-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018494-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018494-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018494-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018494-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018494-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018494-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018494-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018494-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018494-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018494-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018494-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018494-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018494-001	AT	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
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier application applno (NDA): 018494 application number: NDA018494 ndc (product): 0338-0114

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0114	Lactated Ringers	sodium chloride, sodium lactate, potassium chloride, calcium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0114	Lactated Ringers	sodium chloride, sodium lactate, potassium chloride, calcium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0114	Lactated Ringers	sodium chloride, sodium lactate, potassium chloride, calcium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0114	Lactated Ringers	sodium chloride, sodium lactate, potassium chloride, calcium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0114	Lactated Ringers	sodium chloride, sodium lactate, potassium chloride, calcium chloride	Baxter Healthcare Corporation	NDA	Current