Potassium Chloride in Dextrose

Product NDC: 0990-7905
11-digit product format: 009907905
Labeler code: 0990
Product ID: 0990-7905_357fc68c-2f4c-4f4c-9e26-a66ff54c59ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextrose monohydrate and potassium chloride injection, solution
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: ICU Medical Inc.
Application: NDA018371
Marketing category: NDA
Marketing start: 2020-11-20
Substance: DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE
Active strength: 5; .149 g/100mL; g/100mL
Pharmacologic classes: Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018371-002	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;298MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018371-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018371-001	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;149MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N018371-003	AP	1	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROSE MONOHYDRATE	5 g/100mL
POTASSIUM CHLORIDE	.149 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309783	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
02d694b5-3600-4d55-bd5c-924abaec5315	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
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
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
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
5668b646-cd56-c3c7-bdea-3f6b1a8840db	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
0990-7905-09	Potassium Chloride in Dextrose	1 in 1 POUCH	INJECTION, SOLUTION	1		7
0990-7905-09	Potassium Chloride in Dextrose	12 in 1 CASE	INJECTION, SOLUTION	12		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0990-7905-09	ML - Milliliter	0990-7905	0e07bac0-20e0-4ace-abf6-bca12cca0691	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0990-7905	POTASSIUM CHLORIDE IN DEXTROSE (DEXTROSE MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTION) INJECTION, SOLUTION [ICU MEDICAL INC.]	5	Current NDC, Legacy NDC, 2 package rows	20231202_02d694b5-3600-4d55-bd5c-924abaec5315.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	DEXTROSE MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTION	ICU Medical Inc.	02d694b5-3600-4d55-bd5c-924abaec5315	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018371 application number: NDA018371 ndc (product): 0990-7905

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309783	potassium chloride 20 MEQ / glucose 5 % in 1000 ML Injection	PSN	02d694b5-3600-4d55-bd5c-924abaec5315	7
309783	1000 ML glucose 50 MG/ML / potassium chloride 0.02 MEQ/ML Injection	SCD	02d694b5-3600-4d55-bd5c-924abaec5315	7
309783	1000 ML Glucose 50 MG/ML / K+ Chloride 0.02 MEQ/ML Injection	SY	02d694b5-3600-4d55-bd5c-924abaec5315	7
309783	1000 ML Glucose 50 MG/ML / Pot Chloride 0.02 MEQ/ML Injection	SY	02d694b5-3600-4d55-bd5c-924abaec5315	7
309783	dextrose 5 % / potassium chloride 20 MEQ per 1000 ML Injection	SY	02d694b5-3600-4d55-bd5c-924abaec5315	7
309783	potassium chloride 20 MEQ / dextrose 5 % per 1000 ML Injection	SY	02d694b5-3600-4d55-bd5c-924abaec5315	7
309783	potassium chloride 20 MEQ / glucose 5 % per 1000 ML Injection	SY	02d694b5-3600-4d55-bd5c-924abaec5315	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0990-7905-09	00990790509	12 POUCH in 1 CASE (0990-7905-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG	12 pouch	2020-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POTASSIUM CHLORIDE in Dextrose Injection, USP	ICU Medical Inc.	2025-10-30	HUMAN PRESCRIPTION DRUG LABEL	10