DEXTROSE

Product NDC: 0338-9653
11-digit product format: 003389653
Labeler code: 0338
Product ID: 0338-9653_b28d6bb9-8496-48bd-b6aa-f67996d0829c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextrose monohydrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA016673
Marketing category: NDA
Marketing start: 1971-03-04
Substance: DEXTROSE MONOHYDRATE
Active strength: 5 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N016673-001	AP
N016673-003	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 2 of 3 · 86 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
2022-03-09 01:35 UTC	2022-03	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016673-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016673-003	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-10-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N016673-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016673-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016673-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016673-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016673-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016673-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016673-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016673-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016673-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016673-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016673-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016673-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016673-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016673-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016673-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016673-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016673-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016673-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016673-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016673-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016673-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016673-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016673-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016673-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016673-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016673-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016673-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016673-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016673-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016673-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016673-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016673-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016673-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016673-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016673-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016673-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016673-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016673-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016673-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016673-003	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1795607	Internal RxNorm lookup
1795609	Internal RxNorm lookup
1795610	Internal RxNorm lookup
1795612	Internal RxNorm lookup
1795616	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
36e9478c-5df0-4b47-b97d-de3626d7cb29	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
0338-9653-60	DEXTROSE	100 mL in 1 BAG	INJECTION, SOLUTION	100		10
0338-9653-60	DEXTROSE	60 in 1 CARTON	INJECTION, SOLUTION	60		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-9653-60	ML - Milliliter	0338-9653	03f1d730-640c-4a5a-802f-d82e0e2f91c3	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9653	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	10	Current NDC, 2 package rows	20250516_36e9478c-5df0-4b47-b97d-de3626d7cb29.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	Baxter Healthcare Corporation	3bb406a9-f5cb-403a-b1bb-5c4facbea3d5	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016673 application number: NDA016673
DEXTROSE	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	36e9478c-5df0-4b47-b97d-de3626d7cb29	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016673 application number: NDA016673 ndc (product): 0338-9653

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
1795609	dextrose 5 % in 100 ML Injection	PSN	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795612	dextrose 5 % in 1000 ML Injection	PSN	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795610	dextrose 5 % in 250 ML Injection	PSN	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795616	dextrose 5 % in 50 ML Injection	PSN	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795607	dextrose 5 % in 500 ML Injection	PSN	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795609	100 ML glucose 50 MG/ML Injection	SCD	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795612	1000 ML glucose 50 MG/ML Injection	SCD	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795610	250 ML glucose 50 MG/ML Injection	SCD	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795616	50 ML glucose 50 MG/ML Injection	SCD	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795607	500 ML glucose 50 MG/ML Injection	SCD	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795609	dextrose 5 % per 100 ML Injection	SY	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795612	dextrose 5 % per 1000 ML Injection	SY	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795610	dextrose 5 % per 250 ML Injection	SY	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795616	dextrose 5 % per 50 ML Injection	SY	36e9478c-5df0-4b47-b97d-de3626d7cb29	10
1795607	dextrose 5 % per 500 ML Injection	SY	36e9478c-5df0-4b47-b97d-de3626d7cb29	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-9653-60	00338965360	60 BAG in 1 CARTON (0338-9653-60) / 100 mL in 1 BAG	60 bag	2024-08-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXTROSE	Baxter Healthcare Corporation \| Bieffe Medital SA	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	12