LACTATED RINGERS

Product NDC: 63323-164
11-digit product format: 633230164
Labeler code: 63323
Product ID: 63323-164_3a522e0e-e194-4ad6-91da-16a0bb1ca7e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA209338
Marketing category: ANDA
Marketing start: 2019-01-28
Substance: CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength: 20; 30; 600; 310 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209338-001	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		2019-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209338-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209338-001	LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	2019-01-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209338-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209338-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209338-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209338-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209338-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209338-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209338-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209338-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209338-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209338-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209338-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209338-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209338-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209338-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209338-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209338-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209338-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209338-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209338-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209338-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209338-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209338-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209338-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209338-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209338-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209338-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209338-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209338-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209338-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209338-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209338-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209338-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209338-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209338-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209338-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209338-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209338-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209338-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209338-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209338-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: LACTATED RINGERS
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
451W47IQ8X	Internal UNII lookup
TU7HW0W0QT	Internal UNII lookup
660YQ98I10	Internal UNII lookup
M4I0D6VV5M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
847630	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7a723a23-3bc1-4f69-b82f-d06a35dc68d6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-164-24	LACTATED RINGERS	250 mL in 1 BAG	INJECTION, SOLUTION	250	5
63323-164-25	LACTATED RINGERS	500 mL in 1 BAG	INJECTION, SOLUTION	500	5
63323-164-26	LACTATED RINGERS	1000 mL in 1 BAG	INJECTION, SOLUTION	1000	5
63323-164-74	LACTATED RINGERS	30 in 1 CASE	INJECTION, SOLUTION	30	5
63323-164-75	LACTATED RINGERS	20 in 1 CASE	INJECTION, SOLUTION	20	5
63323-164-76	LACTATED RINGERS	10 in 1 CASE	INJECTION, SOLUTION	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-164-24	ML - Milliliter	63323-164	6be66afb-9adf-4b49-9a4d-ce2e5c4219a4	1	2019-08-06
63323-164-25	ML - Milliliter	63323-164	87143755-8115-4701-9e19-6baf61fd0afe	1	2019-08-06
63323-164-26	ML - Milliliter	63323-164	46c129e4-be51-4170-b362-2bcd9c9a9862	1	2019-08-06
63323-164-74	ML - Milliliter	63323-164	af8141e7-0832-4dbc-8aea-a0d1b21281e2	1	2019-08-06
63323-164-75	ML - Milliliter	63323-164	6e5efa64-f4c4-4cad-b613-36d4c15b7904	1	2019-08-06
63323-164-76	ML - Milliliter	63323-164	2ffca376-8c86-423b-ade3-03e5f954971c	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-164	LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 6 package rows	20240427_7a723a23-3bc1-4f69-b82f-d06a35dc68d6.zip

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 · 3 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	Becton Dickinson and Company	bb2ad9cd-5d9a-4337-be61-0842d738c79e	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209338 application number: ANDA209338
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Fresenius Kabi USA, LLC	8fce1477-991f-4b43-bf05-a80bad897262	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209338 application number: ANDA209338
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Fresenius Kabi USA, LLC	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209338 application number: ANDA209338 ndc (product): 63323-164

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
847630	lactated Ringers Injectable Solution	PSN	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	5
847630	calcium chloride 0.2 MG/ML / potassium chloride 0.3 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable Solution	SCD	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	5
847630	calcium chloride 0.2 MG/ML / K+ chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable Solution	SY	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	5
847630	calcium chloride 0.2 MG/ML / Pot chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable Solution	SY	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	5
847630	calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringer's Injectable Solution	SY	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-164-24	63323016424	250 mL in 1 BAG	250 ml					Historical
63323-164-25	63323016425	500 mL in 1 BAG	500 ml					Historical
63323-164-26	63323016426	1000 mL in 1 BAG	1000 ml					Historical
63323-164-74	63323016474	30 BAG in 1 CASE (63323-164-74) / 250 mL in 1 BAG (63323-164-24)	30 bag	2019-01-28	0000-00-00	No	No	Current
63323-164-75	63323016475	20 BAG in 1 CASE (63323-164-75) / 500 mL in 1 BAG (63323-164-25)	20 bag	2019-01-28	0000-00-00	No	No	Current
63323-164-76	63323016476	10 BAG in 1 CASE (63323-164-76) / 1000 mL in 1 BAG (63323-164-26)	10 bag	2019-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lactated Ringer's Injection, USP	Fresenius Kabi USA, LLC \| HP Halden Pharma AS	2024-04-24	HUMAN PRESCRIPTION DRUG LABEL	5