Lactated Ringers

Product NDC: 0409-7828
11-digit product format: 004097828
Labeler code: 0409
Product ID: 0409-7828_c7d07fd4-5ab8-420c-8ec3-4d8ec88f5d35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE
Dosage form: IRRIGANT
Route: IRRIGATION
Labeler: Hospira, Inc.
Application: NDA019416
Marketing category: NDA
Marketing start: 2005-05-16
Marketing end: 2021-08-01
Substance: SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE
Active strength: 600 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes: Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0409-7828		D	Discontinued by firm		2026-09-09
excluded package	package	0409-7828	0409-7828-08	D	Discontinued by firm		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-7828-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-7828-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-7828-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-7828-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-7828-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-7828-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-7828-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-7828-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-7828-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-7828-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0409-7828-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0409-7828-08	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N019416-001	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	RLD, RS	1986-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019416-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019416-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS	1986-01-17	`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	N019416-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019416-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019416-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019416-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019416-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019416-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019416-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019416-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019416-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019416-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019416-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019416-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019416-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019416-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019416-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019416-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019416-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019416-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019416-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019416-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019416-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019416-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019416-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019416-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019416-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019416-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019416-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019416-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019416-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019416-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019416-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019416-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019416-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019416-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019416-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019416-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019416-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019416-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019416-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019416-001	AT	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-7828-08	ML - Milliliter	0409-7828	521acb81-36a7-47f2-8585-5568053cd4c7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM CHLORIDE	ACTIVE INGREDIENT	M4I0D6VV5M	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5
SODIUM LACTATE	ACTIVE INGREDIENT	TU7HW0W0QT	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5
LACTIC ACID	ACTIVE MOIETY	33X04XA5AT	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]	5

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, AND CALCIUM CHLORIDE	ICU Medical Inc.	b96eb740-749a-4d3a-ae63-b8e3947cad30	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019416 application number: NDA019416

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
TU7HW0W0QT	SODIUM LACTATE	72-17-3	SODIUM LACTATE
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE
M4I0D6VV5M	CALCIUM CHLORIDE	10035-04-8	CALCIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-7828-08	00409782808	4 POUCH in 1 CASE (0409-7828-08) > 1 BAG in 1 POUCH > 3000 mL in 1 BAG	4 pouch	2005-05-16	2021-08-01	No	No	Current