Potassium Chloride in Dextrose and Sodium Chloride

Product NDC: 0338-0663
11-digit product format: 003380663
Labeler code: 0338
Product ID: 0338-0663_34c74d23-f49a-4e1c-9ffe-9a200d0fffe7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride, Dextrose Monohydrate and Sodium Chloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: NDA018037
Marketing category: NDA
Marketing start: 1979-02-02
Substance: DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Active strength: 5; 150; 200 g/100mL; mg/100mL; mg/100mL
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0338-0663	0338-0663-03	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0338-0663	0338-0663-03	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0338-0663	0338-0663-03	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13
N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13
N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13
N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13
N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-product	TE code
N018037-001	AP
N018037-002	AP
N018037-003	AP
N018037-004	AP
N018037-005	AP
N018037-006	AP
N018037-007	AP
N018037-008	AP
N018037-009	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 10 · 378 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	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 378 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	N018037-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-009	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018037-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-009	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-009	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018037-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-009	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-004	AP	1	`fd3edfee7708…`

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Chloride in Dextrose and Sodium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	150 mg/100mL
DEXTROSE MONOHYDRATE	5 g/100mL
SODIUM CHLORIDE	200 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
615099	Internal RxNorm lookup
615100	Internal RxNorm lookup
615107	Internal RxNorm lookup
615111	Internal RxNorm lookup
630796	Internal RxNorm lookup
1863605	Internal RxNorm lookup
1863607	Internal RxNorm lookup
1863973	Internal RxNorm lookup
1863975	Internal RxNorm lookup
1863988	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
c553fed1-3de5-4826-8eff-633b5923bf0b	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
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
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	Strength	SPL version
0338-0663-03	Potassium Chloride in Dextrose and Sodium Chloride	500 mL in 1 BAG	INJECTION, SOLUTION	500		17
0338-0663-04	Potassium Chloride in Dextrose and Sodium Chloride	1000 mL in 1 BAG	INJECTION, SOLUTION	1000		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0663-03	ML - Milliliter	0338-0663	2564558a-f438-4e06-b9f6-4a84922f9d22	1	2012-07-24
0338-0663-04	ML - Milliliter	0338-0663	61ecfb2d-9a65-4f22-ba41-79499c20d6ad	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROSE MONOHYDRATE	ACTIVE INGREDIENT	LX22YL083G	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
ANHYDROUS DEXTROSE	ACTIVE MOIETY	5SL0G7R0OK	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0663	POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	15	Current NDC, Legacy NDC, 2 package rows	20240910_c553fed1-3de5-4826-8eff-633b5923bf0b.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	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Baxter Healthcare Company	c553fed1-3de5-4826-8eff-633b5923bf0b	2019-02-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018037 application number: NDA018037 ndc (product): 0338-0663

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
1863975	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.225 % in 500 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863607	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % in 500 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
630796	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863973	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.225 % in 1000 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863988	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.3 % in 1000 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863605	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615107	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.9 % in 1000 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615099	potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615100	potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % in 1000 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615111	potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.9 % in 1000 ML Injection	PSN	c553fed1-3de5-4826-8eff-633b5923bf0b	17
630796	1000 ML glucose 50 MG/ML / potassium chloride 0.01 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863973	1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 2.25 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863988	1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 3 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863605	1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615107	1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 9 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615099	1000 ML glucose 50 MG/ML / potassium chloride 0.03 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615100	1000 ML glucose 50 MG/ML / potassium chloride 0.04 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615111	1000 ML glucose 50 MG/ML / potassium chloride 0.04 MEQ/ML / sodium chloride 9 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863975	500 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 2.25 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863607	500 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML / sodium chloride 4.5 MG/ML Injection	SCD	c553fed1-3de5-4826-8eff-633b5923bf0b	17
630796	1000 ML Glucose 50 MG/ML / K+ Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863973	1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863988	1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 3 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863605	1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615107	1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 9 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615099	1000 ML Glucose 50 MG/ML / K+ Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615100	1000 ML Glucose 50 MG/ML / K+ Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615111	1000 ML Glucose 50 MG/ML / K+ Chloride 0.04 MEQ/ML / NaCl 9 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
630796	1000 ML Glucose 50 MG/ML / Pot Chloride 0.01 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863973	1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863988	1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 3 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863605	1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615107	1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 9 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615099	1000 ML Glucose 50 MG/ML / Pot Chloride 0.03 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615100	1000 ML Glucose 50 MG/ML / Pot Chloride 0.04 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615111	1000 ML Glucose 50 MG/ML / Pot Chloride 0.04 MEQ/ML / NaCl 9 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863975	500 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863607	500 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863975	500 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 2.25 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863607	500 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML / NaCl 4.5 MG/ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863975	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.225 % per 500 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
630796	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863607	potassium chloride 10 MEQ / dextrose 5 % / sodium chloride 0.45 % per 500 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863973	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.225 % per 1000 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863988	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.3 % per 1000 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
1863605	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615107	potassium chloride 20 MEQ / dextrose 5 % / sodium chloride 0.9 % per 1000 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615099	potassium chloride 30 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615100	potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.45 % per 1000 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17
615111	potassium chloride 40 MEQ / dextrose 5 % / sodium chloride 0.9 % per 1000 ML Injection	SY	c553fed1-3de5-4826-8eff-633b5923bf0b	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-0663-03	00338066303	500 mL in 1 BAG (0338-0663-03)	500 ml	1979-02-02	0000-00-00	No	No	Current
0338-0663-04	00338066304	1000 mL in 1 BAG (0338-0663-04)	1000 ml	1979-02-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Chloride in Dextrose and Sodium Chloride	Baxter Healthcare Company \| Baxter Healthcare Corporation	2019-02-21	HUMAN PRESCRIPTION DRUG LABEL	18