Dextrose

Product NDC: 0990-7938
11-digit product format: 009907938
Labeler code: 0990
Product ID: 0990-7938_43f81a41-0a45-45f5-840c-768d768edd3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextrose monohydrate
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: ICU Medical, Inc.
Application: NDA018080
Marketing category: NDA
Marketing start: 2019-11-20
Substance: DEXTROSE MONOHYDRATE
Active strength: 10 g/100mL
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 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
N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	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
N018080-001	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	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018080-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	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	N018080-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018080-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018080-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018080-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018080-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018080-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018080-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018080-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018080-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018080-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018080-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018080-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018080-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018080-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018080-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018080-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018080-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018080-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018080-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018080-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018080-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018080-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018080-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018080-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018080-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018080-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018080-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018080-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018080-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018080-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018080-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018080-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018080-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018080-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018080-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018080-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018080-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018080-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018080-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018080-001	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	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1795477	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
cb578dba-094c-4787-951d-763d12fd06e1	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	Strength	SPL version
0990-7938-19	Dextrose	1 in 1 POUCH	INJECTION, SOLUTION, CONCENTRATE	1		15
0990-7938-19	Dextrose	12 in 1 CASE	INJECTION, SOLUTION, CONCENTRATE	12		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0990-7938-19	ML - Milliliter	0990-7938	b33fcc75-b3d8-482d-8b8c-ca03b1740180	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0990-7938	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION, CONCENTRATE [ICU MEDICAL INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240711_cb578dba-094c-4787-951d-763d12fd06e1.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 · 2 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): 018080 application number: NDA018080
Dextrose	DEXTROSE MONOHYDRATE	ICU Medical, Inc.	cb578dba-094c-4787-951d-763d12fd06e1	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018080 application number: NDA018080 ndc (product): 0990-7938

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
1795477	dextrose 10 % in 500 ML Injection	PSN	cb578dba-094c-4787-951d-763d12fd06e1	15
1795477	500 ML glucose 100 MG/ML Injection	SCD	cb578dba-094c-4787-951d-763d12fd06e1	15
1795477	dextrose 10 % per 500 ML Injection	SY	cb578dba-094c-4787-951d-763d12fd06e1	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0990-7938-19	00990793819	12 POUCH in 1 CASE (0990-7938-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG	12 pouch	2019-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextrose - ICU Medical, Inc. \| Hospira, Inc.	ICU Medical, Inc. \| Hospira, Inc.	2025-11-01	HUMAN PRESCRIPTION DRUG LABEL	16