Dextrose

Product NDC: 0264-7387
11-digit product format: 002647387
Labeler code: 0264
Product ID: 0264-7387_200c4b9e-283a-4dea-b33a-9bb4936b2b99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextrose
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: B. Braun Medical Inc.
Application: NDA019626
Marketing category: NDA
Marketing start: 2015-02-19
Substance: DEXTROSE
Active strength: 70 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	DEXTROSE	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02
N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02
N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	DEXTROSE	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02
N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02
N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019626-002	AP
N019626-004	AP
N019626-005	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 6 · 210 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
2026-08-18 06:07:40	2026-07	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-001	DEXTROSE 2.5% IN PLASTIC CONTAINER	2.5GM/100ML	INJECTABLE / INJECTION			1988-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-002	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-003	DEXTROSE 7.7% IN PLASTIC CONTAINER	7.7GM/100ML	INJECTABLE / INJECTION			1988-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-004	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-005	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2015-02-18	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N019626-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019626-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019626-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019626-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019626-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019626-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019626-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019626-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019626-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019626-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019626-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019626-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019626-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019626-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019626-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019626-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019626-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019626-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019626-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019626-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019626-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019626-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019626-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019626-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019626-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019626-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019626-002	AP	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dextrose
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROSE	70 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IY9XDZ35W2	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
8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0	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
0264-7387-50	Dextrose	4 in 1 CASE	SOLUTION	4		21
0264-7387-50	Dextrose	2000 mL in 1 CONTAINER	SOLUTION	2000		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-7387-50	ML - Milliliter	0264-7387	3c7b215c-76f9-4a0e-b67f-bd9c4d62387f	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROSE	ACTIVE INGREDIENT	IY9XDZ35W2	DEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]	15
DEXTROSE	ACTIVE MOIETY	IY9XDZ35W2	DEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]	15
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0264-7387	DEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]	21	Current NDC, Legacy NDC, 2 package rows	20241213_8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0.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	B. Braun Medical Inc.	8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019626 application number: NDA019626 ndc (product): 0264-7387
DEXTROSE	DEXTROSE	B. Braun Medical Inc.	085614c7-ada4-4e2c-87c0-c9bc2f18365a	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019626 application number: NDA019626

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
237656	dextrose 70 % Injectable Solution	PSN	8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0	21
237656	glucose 700 MG/ML Injectable Solution	SCD	8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0	21
237656	dextrose 70 % Injectable Solution	SY	8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0264-7387-50	00264738750	4 CONTAINER in 1 CASE (0264-7387-50) / 2000 mL in 1 CONTAINER	4 container	2015-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
70% Dextrose Injection USP	B. Braun Medical Inc. \| B. Braun US Pharmaceutical Manufacturing LLC	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	21