Dextrose

Product NDC: 0990-7923
11-digit product format: 009907923
Labeler code: 0990
Product ID: 0990-7923_ea5b9574-2321-442f-b550-3ac4f10dcaf8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextrose monohydrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: ICU Medical, Inc.
Application: NDA016367
Marketing category: NDA
Marketing start: 2019-07-15
Substance: DEXTROSE MONOHYDRATE
Active strength: 5 g/100mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0990-7923		D	Discontinued by firm	2026-08-17
excluded package	package	0990-7923	0990-7923-06	D	Discontinued by firm	2026-08-17
excluded package	package	0990-7923	0990-7923-11	D	Discontinued by firm	2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0990-7923-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0990-7923-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0990-7923-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0990-7923-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0990-7923-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0990-7923-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0990-7923-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0990-7923-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0990-7923-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0990-7923-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0990-7923-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0990-7923-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0990-7923-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0990-7923-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0990-7923-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0990-7923-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0990-7923-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0990-7923-11	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0990-7923-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0990-7923-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0990-7923-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0990-7923-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0990-7923-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0990-7923-11	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016367-002	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N016367-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016367-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016367-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016367-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016367-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016367-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016367-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016367-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016367-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016367-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016367-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016367-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016367-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016367-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016367-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016367-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016367-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016367-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016367-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016367-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016367-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016367-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016367-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016367-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016367-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016367-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016367-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016367-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016367-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016367-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016367-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016367-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016367-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016367-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016367-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016367-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016367-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016367-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016367-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016367-002	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROSE MONOHYDRATE	5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1795477	Internal RxNorm lookup
1795480	Internal RxNorm lookup
1795481	Internal RxNorm lookup
1795607	Internal RxNorm lookup
1795609	Internal RxNorm lookup
1795610	Internal RxNorm lookup
1795612	Internal RxNorm lookup
1795616	Internal RxNorm lookup
1795618	Internal RxNorm lookup
1795621	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
8b25b7e0-703e-4b43-a4eb-52863511602d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0990-7923-13	Dextrose	1 in 1 POUCH	INJECTION, SOLUTION	1	17
0990-7923-13	Dextrose	48 in 1 CASE	INJECTION, SOLUTION	48	17
0990-7923-20	Dextrose	12 in 1 CASE	INJECTION, SOLUTION	12	17
0990-7923-20	Dextrose	4 in 1 POUCH	INJECTION, SOLUTION	4	17
0990-7923-23	Dextrose	1 in 1 POUCH	INJECTION, SOLUTION	1	17
0990-7923-23	Dextrose	48 in 1 CASE	INJECTION, SOLUTION	48	17
0990-7923-36	Dextrose	20 in 1 CASE	INJECTION, SOLUTION	20	17
0990-7923-36	Dextrose	4 in 1 POUCH	INJECTION, SOLUTION	4	17
0990-7923-37	Dextrose	20 in 1 CASE	INJECTION, SOLUTION	20	17
0990-7923-37	Dextrose	4 in 1 POUCH	INJECTION, SOLUTION	4	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0990-7923-11	ML - Milliliter	0990-7923	60ec6338-519f-40f9-ac1b-5ed50ef046c0	1	2020-07-13
0990-7923-13	ML - Milliliter	0990-7923	3f5c8d87-7337-4c81-8767-025b697b649d	1	2020-07-13
0990-7923-20	ML - Milliliter	0990-7923	988f9a36-8659-4d88-9d99-ceea8e9d1992	1	2020-05-08
0990-7923-23	ML - Milliliter	0990-7923	d3bca08f-e6aa-45ef-87b5-64cee7e9d45a	1	2020-06-05
0990-7923-36	ML - Milliliter	0990-7923	f9612d2b-2ccb-4b56-af07-3e28670a4e6c	1	2020-05-08
0990-7923-37	ML - Milliliter	0990-7923	83675906-284f-461f-9781-d3fcc9e166af	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0990-7923	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [ICU MEDICAL INC.]	12	Current NDC, Legacy NDC, 10 package rows	20240711_8b25b7e0-703e-4b43-a4eb-52863511602d.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
Dextrose	DEXTROSE MONOHYDRATE	ICU Medical, Inc.	8b25b7e0-703e-4b43-a4eb-52863511602d	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016367 application number: NDA016367 ndc (product): 0990-7923

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LX22YL083G	DEXTROSE MONOHYDRATE	77938-63-7	DEXTROSE MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1795481	dextrose 10 % in 1000 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795480	dextrose 10 % in 250 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795477	dextrose 10 % in 500 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795609	dextrose 5 % in 100 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795612	dextrose 5 % in 1000 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795621	dextrose 5 % in 150 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795618	dextrose 5 % in 25 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795610	dextrose 5 % in 250 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795616	dextrose 5 % in 50 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795607	dextrose 5 % in 500 ML Injection	PSN	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795609	100 ML glucose 50 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795481	1000 ML glucose 100 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795612	1000 ML glucose 50 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795621	150 ML glucose 50 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795618	25 ML glucose 50 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795480	250 ML glucose 100 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795610	250 ML glucose 50 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795616	50 ML glucose 50 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795477	500 ML glucose 100 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795607	500 ML glucose 50 MG/ML Injection	SCD	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795481	dextrose 10 % per 1000 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795480	dextrose 10 % per 250 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795477	dextrose 10 % per 500 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795609	dextrose 5 % per 100 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795612	dextrose 5 % per 1000 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795621	dextrose 5 % per 150 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795618	dextrose 5 % per 25 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795610	dextrose 5 % per 250 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795616	dextrose 5 % per 50 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17
1795607	dextrose 5 % per 500 ML Injection	SY	8b25b7e0-703e-4b43-a4eb-52863511602d	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0990-7923-06	00990792306	60 BAG in 1 CASE (0990-7923-06) > 50 mL in 1 BAG	60 bag	2019-10-01	0000-00-00	No	No	Current
0990-7923-11	00990792311	60 BAG in 1 CASE (0990-7923-11) > 100 mL in 1 BAG	60 bag	2019-10-01	0000-00-00	No	No	Current
0990-7923-13	00990792313	48 POUCH in 1 CASE (0990-7923-13) / 1 BAG in 1 POUCH / 50 mL in 1 BAG	48 pouch	2019-08-01	0000-00-00	No	No	Current
0990-7923-20	00990792320	12 POUCH in 1 CASE (0990-7923-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG	12 pouch	2019-08-01	0000-00-00	No	No	Current
0990-7923-23	00990792323	48 POUCH in 1 CASE (0990-7923-23) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	48 pouch	2019-08-01	0000-00-00	No	No	Current
0990-7923-36	00990792336	20 POUCH in 1 CASE (0990-7923-36) / 4 BAG in 1 POUCH / 50 mL in 1 BAG	20 pouch	2019-07-15	0000-00-00	No	No	Current
0990-7923-37	00990792337	20 POUCH in 1 CASE (0990-7923-37) / 4 BAG in 1 POUCH / 100 mL in 1 BAG	20 pouch	2019-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextrose	ICU Medical, Inc. \| Hospira, Inc. \| Otsuka ICU Medical LLC	2025-11-02	HUMAN PRESCRIPTION DRUG LABEL	18
Dextrose - ICU Medical Inc.	ICU Medical Inc.	2021-03-08	HUMAN PRESCRIPTION DRUG LABEL	4