Lactated Ringers

Product NDC: 85766-311
Requested package NDC: 85766-311-00
11-digit product format: 857660311
Labeler code: 85766
Product ID: 85766-311_5ee30e4f-8b54-e2a0-e063-6294a90a0282
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium chloride, potassium chloride, sodium lactate and calcium chloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sportpharm LLC
Application: NDA016682
Marketing category: NDA
Marketing start: 1971-03-22
Substance: SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE
Active strength: 600; 310; 30; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes: Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/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
N016682-001	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 · 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
2026-10-15 13:18:30	2026-09	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016682-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`

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	N016682-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016682-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016682-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016682-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016682-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016682-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016682-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016682-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016682-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016682-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016682-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016682-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016682-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016682-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016682-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016682-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016682-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016682-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016682-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016682-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016682-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016682-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016682-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016682-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016682-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016682-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016682-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016682-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016682-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016682-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016682-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016682-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016682-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016682-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016682-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016682-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016682-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016682-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016682-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016682-001	AP	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Lactated Ringers
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM CHLORIDE	600 mg/100mL
SODIUM LACTATE	310 mg/100mL
POTASSIUM CHLORIDE	30 mg/100mL
CALCIUM CHLORIDE	20 mg/100mL

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, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE	Baxter Healthcare Company	dad7735c-709b-40ea-ab7a-15577e24a966	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016682 application number: NDA016682

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	Sample	Exclude flag	Status
85766-311-00	85766031100	1000 mL in 1 BAG (85766-311-00)	1000 ml	2026-10-28	No	No	Current