Potassium Chloride in Dextrose and Sodium Chloride

Product NDC: 65219-119
11-digit product format: 652190119
Labeler code: 65219
Product ID: 65219-119_12195392-e623-4978-a1f4-33b5dbd642c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA213445
Marketing category: ANDA
Marketing start: 2022-08-31
Substance: DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Active strength: 50; 2.98; 9 g/1000mL; g/1000mL; g/1000mL
Pharmacologic classes: Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP		2021-03-09
A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP		2021-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213445-001	AP
A213445-002	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 · 68 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	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION		2021-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213445-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;149MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213445-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	5GM/100ML;298MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A213445-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213445-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213445-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213445-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213445-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213445-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213445-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213445-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213445-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213445-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213445-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213445-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213445-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213445-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213445-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213445-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213445-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213445-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213445-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213445-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213445-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213445-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213445-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213445-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213445-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213445-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213445-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213445-002	AP	1	`8072bd15b7f6…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213445-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213445-002	AP	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213445-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213445-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213445-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213445-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213445-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213445-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213445-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213445-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213445-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213445-002	AP	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Chloride in Dextrose and Sodium Chloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROSE MONOHYDRATE	50 g/1000mL
SODIUM CHLORIDE	2.98 g/1000mL
POTASSIUM CHLORIDE	9 g/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
451W47IQ8X	Internal UNII lookup
LX22YL083G	Internal UNII lookup
660YQ98I10	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
615107	Internal RxNorm lookup
615111	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
97001218-086c-430a-9e0d-6c7031c91d94	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
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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
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
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
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
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19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65219-119-01	Potassium Chloride in Dextrose and Sodium Chloride	1000 mL in 1 BAG	INJECTION, SOLUTION	1000		3
65219-119-10	Potassium Chloride in Dextrose and Sodium Chloride	10 in 1 CASE	INJECTION, SOLUTION	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-119-01	ML - Milliliter	65219-119	de6c6d64-b05b-43a4-994a-885592cdaa54	1	2023-06-06
65219-119-10	ML - Milliliter	65219-119	64cfa3b8-d153-4800-a3a0-73c6dcc59e44	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-119	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20240509_97001218-086c-430a-9e0d-6c7031c91d94.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	97001218-086c-430a-9e0d-6c7031c91d94	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213445 application number: ANDA213445 ndc (product): 65219-119

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LX22YL083G	DEXTROSE MONOHYDRATE	77938-63-7	DEXTROSE MONOHYDRATE
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
615107	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.9 % in 1000 ML Injection	PSN	97001218-086c-430a-9e0d-6c7031c91d94	3
615111	potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.9 % in 1000 ML Injection	PSN	97001218-086c-430a-9e0d-6c7031c91d94	3
615107	1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 9 MG/ML Injection	SCD	97001218-086c-430a-9e0d-6c7031c91d94	3
615111	1000 ML glucose 50 MG/ML / potassium chloride 0.04 MEQ/ML / sodium chloride 9 MG/ML Injection	SCD	97001218-086c-430a-9e0d-6c7031c91d94	3
615107	1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 9 MG/ML Injection	SY	97001218-086c-430a-9e0d-6c7031c91d94	3
615111	1000 ML Glucose 50 MG/ML / K+ Chloride 0.04 MEQ/ML / NaCl 9 MG/ML Injection	SY	97001218-086c-430a-9e0d-6c7031c91d94	3
615107	1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 9 MG/ML Injection	SY	97001218-086c-430a-9e0d-6c7031c91d94	3
615111	1000 ML Glucose 50 MG/ML / Pot Chloride 0.04 MEQ/ML / NaCl 9 MG/ML Injection	SY	97001218-086c-430a-9e0d-6c7031c91d94	3
615107	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.9 % per 1000 ML Injection	SY	97001218-086c-430a-9e0d-6c7031c91d94	3
615111	potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.9 % per 1000 ML Injection	SY	97001218-086c-430a-9e0d-6c7031c91d94	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65219-119-01	65219011901	1000 mL in 1 BAG	1000 ml					Historical
65219-119-10	65219011910	10 BAG in 1 CASE (65219-119-10) / 1000 mL in 1 BAG (65219-119-01)	10 bag	2022-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE	Fresenius Kabi USA, LLC \| HP Halden Pharma AS	2024-05-06	HUMAN PRESCRIPTION DRUG LABEL	3