Dextrose

Product NDC: 70518-4452
11-digit product format: 705184452
Labeler code: 70518
Product ID: 70518-4452_3d33f2c3-fdfd-2c0d-e063-6394a90a0bfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextrose monohydrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: NDA019445
Marketing category: NDA
Marketing start: 2025-08-22
Substance: DEXTROSE MONOHYDRATE
Active strength: 250 mg/mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019445-001	DEXTROSE 50%	DEXTROSE	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03
N019445-002	DEXTROSE 25%	DEXTROSE	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019445-001	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 3 · 92 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	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019445-001	DEXTROSE 50% IN PLASTIC CONTAINER	500MG/ML	INJECTABLE / INJECTION		RLD	1986-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019445-003	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION		RLD	2014-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019445-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019445-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019445-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019445-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019445-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019445-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019445-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019445-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019445-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019445-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019445-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019445-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019445-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019445-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019445-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019445-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019445-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019445-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019445-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019445-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019445-001	AP	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019445-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019445-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019445-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019445-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019445-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019445-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019445-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019445-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019445-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019445-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019445-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019445-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019445-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019445-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROSE MONOHYDRATE	250 mg/mL

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
727518	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
e2638b45-1141-4391-971d-c0dea825e41c	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
70518-4452-0	Dextrose	1 in 1 CARTON	INJECTION, SOLUTION	1		1
70518-4452-1	Dextrose	10 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	10		1

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Infant Dextrose	DEXTROSE	Henry Schein, Inc.	ce71d929-d11e-444c-bd45-e025d5172057	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	672264e3-9709-4bba-2a9d-12bf70c7396a	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	Henry Schein, Inc.	40fd1ac4-39bb-45fb-ba99-4fb65481f231	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	Henry Schein, Inc.	8cf6943f-16e8-4521-863c-09bb0b55e2a9	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	REMEDYREPACK INC.	b8b77421-d687-45aa-82f6-d49bce644c10	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	REMEDYREPACK INC.	e2638b45-1141-4391-971d-c0dea825e41c	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 70518-4452
Dextrose	DEXTROSE MONOHYDRATE	ProPharma Distribution	3842a9c0-8b15-1c94-e063-6394a90ae120	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	763b1cb8-1151-5f59-e053-2991aa0a4e01	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	75c902e8-50e7-a337-e053-2991aa0a2093	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	677a81e5-26ba-2a69-e053-2991aa0a101a	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	ada63d44-3b37-b65d-e053-2a95a90aa088	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
25% Dextrose Infant	25% DEXTROSE INFANT	HF Acquisition Co. LLC, DBA Health First	73d04839-a2bb-65dd-e053-2991aa0a82ca	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	66713d9c-f404-4ec8-e053-2a91aa0a620a	2022-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445

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
727518	dextrose 25 % in 10 ML Prefilled Syringe	PSN	e2638b45-1141-4391-971d-c0dea825e41c	1
727518	10 ML glucose 250 MG/ML Prefilled Syringe	SCD	e2638b45-1141-4391-971d-c0dea825e41c	1
727518	10 ML dextrose 25 % Prefilled Syringe	SY	e2638b45-1141-4391-971d-c0dea825e41c	1
727518	dextrose 2.5 GM per 10 ML Prefilled Syringe	SY	e2638b45-1141-4391-971d-c0dea825e41c	1
727518	dextrose 2500 MG per 10 ML Prefilled Syringe	SY	e2638b45-1141-4391-971d-c0dea825e41c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4452-0	70518445200	1 SYRINGE, PLASTIC in 1 CARTON (70518-4452-0) / 10 mL in 1 SYRINGE, PLASTIC (70518-4452-1)		2025-08-22	No	No	Current
70518-4452-1	70518445201	10 mL in 1 SYRINGE, PLASTIC	10 ml				Historical