Potassium Chloride in Dextrose and Sodium Chloride

Product NDC: 65219-148
11-digit product format: 652190148
Labeler code: 65219
Product ID: 65219-148_93737cd2-f9e0-41e1-9263-2c4ff516395a
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: ANDA213523
Marketing category: ANDA
Marketing start: 2022-08-26
Substance: DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Active strength: 50; 2.98; 4.5 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09
A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09
A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09
A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09
A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A213523-001	AP
A213523-002	AP
A213523-003	AP
A213523-004	AP
A213523-005	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 5 · 162 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	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 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	A213523-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213523-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-005	AP	1	`5bbf6a4d5a75…`

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	4.5 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
615099	Internal RxNorm lookup
615100	Internal RxNorm lookup
630796	Internal RxNorm lookup
1863605	Internal RxNorm lookup
1863607	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
fe5b5182-c859-4c74-b2e0-467be5b2e329	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
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65219-148-08	Potassium Chloride in Dextrose and Sodium Chloride	1000 mL in 1 BAG	INJECTION, SOLUTION	1000		7
65219-148-10	Potassium Chloride in Dextrose and Sodium Chloride	10 in 1 CASE	INJECTION, SOLUTION	10		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-148-08	ML - Milliliter	65219-148	c18e5f9b-1e58-4171-a820-7b2a7dc38d9b	1	2023-06-06
65219-148-10	ML - Milliliter	65219-148	9223d540-8100-4a07-80bc-c4458deb6ded	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-148	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	7	Current NDC, Legacy NDC, 2 package rows	20240509_fe5b5182-c859-4c74-b2e0-467be5b2e329.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	fe5b5182-c859-4c74-b2e0-467be5b2e329	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213523 application number: ANDA213523 ndc (product): 65219-148

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
1863607	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % in 500 ML Injection	PSN	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
630796	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	PSN	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863605	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML Injection	PSN	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615099	potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML Injection	PSN	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615100	potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML Injection	PSN	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
630796	1000 ML glucose 50 MG/ML / potassium chloride 0.01 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863605	1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615099	1000 ML glucose 50 MG/ML / potassium chloride 0.03 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615100	1000 ML glucose 50 MG/ML / potassium chloride 0.04 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863607	500 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
630796	1000 ML Glucose 50 MG/ML / K+ Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863605	1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615099	1000 ML Glucose 50 MG/ML / K+ Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615100	1000 ML Glucose 50 MG/ML / K+ Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
630796	1000 ML Glucose 50 MG/ML / Pot Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863605	1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615099	1000 ML Glucose 50 MG/ML / Pot Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615100	1000 ML Glucose 50 MG/ML / Pot Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863607	500 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863607	500 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
630796	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863607	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 500 ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
1863605	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615099	potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7
615100	potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	SY	fe5b5182-c859-4c74-b2e0-467be5b2e329	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65219-148-08	65219014808	1000 mL in 1 BAG	1000 ml					Historical
65219-148-10	65219014810	10 BAG in 1 CASE (65219-148-10) / 1000 mL in 1 BAG (65219-148-08)	10 bag	2022-08-26	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	7