DEXTROSE

Product NDC: 0338-0719
Requested package NDC: 0338-0719-06
11-digit product format: 003380719
Labeler code: 0338
Product ID: 0338-0719_fa107ac2-32b9-452f-b26c-0a5df79e31ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextrose monohydrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA020047
Marketing category: NDA
Marketing start: 1991-07-02
Substance: DEXTROSE MONOHYDRATE
Active strength: 70 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	DEXTROSE	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02
N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	DEXTROSE	60GM/100ML	INJECTABLE / INJECTION			1991-07-02
N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020047-001	AP
N020047-003	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 1 of 4 · 129 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
2026-09-14 22:38:34	2026-08	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`301d65b070ca…`

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	N020047-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020047-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020047-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020047-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020047-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020047-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020047-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020047-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020047-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020047-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020047-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020047-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020047-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020047-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020047-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020047-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020047-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020047-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020047-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020047-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020047-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020047-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020047-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020047-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020047-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020047-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020047-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020047-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020047-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020047-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020047-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020047-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020047-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020047-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020047-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020047-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020047-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020047-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020047-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020047-003	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	70 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
237656	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
0332f34a-7038-47cc-ba59-d55cad6b73ca	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
0338-0719-06	DEXTROSE	2000 mL in 1 BAG	INJECTION, SOLUTION	2000		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0719-06	ML - Milliliter	0338-0719	deccf3de-d293-4602-b370-605c3bfcd133	1	2012-07-24
0338-0719-13	ML - Milliliter	0338-0719	a86c0f65-a3c5-42cb-8755-d70872f37d75	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROSE MONOHYDRATE	ACTIVE INGREDIENT	LX22YL083G	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
ANHYDROUS DEXTROSE	ACTIVE MOIETY	5SL0G7R0OK	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
Water	INACTIVE INGREDIENT	059QF0KO0R	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0719	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	15	Current NDC, Legacy NDC, 1 package rows	20250516_0332f34a-7038-47cc-ba59-d55cad6b73ca.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	Baxter Healthcare Corporation	0332f34a-7038-47cc-ba59-d55cad6b73ca	2019-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020047 application number: NDA020047 ndc (package): 0338-0719-06 ndc (product): 0338-0719 ndc11 (package): 00338071906

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
237656	dextrose 70 % Injectable Solution	PSN	0332f34a-7038-47cc-ba59-d55cad6b73ca	15
237656	glucose 700 MG/ML Injectable Solution	SCD	0332f34a-7038-47cc-ba59-d55cad6b73ca	15
237656	dextrose 70 % Injectable Solution	SY	0332f34a-7038-47cc-ba59-d55cad6b73ca	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-0719-06	00338071906	2000 mL in 1 BAG (0338-0719-06)	2000 ml	1991-07-02	0000-00-00	No	No	Current