Dextrose

Product NDC: 0409-7517
11-digit product format: 004097517
Labeler code: 0409
Product ID: 0409-7517_2f05a8f1-4651-405c-a66b-8e96a46c1db8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXTROSE MONOHYDRATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA019445
Marketing category: NDA
Marketing start: 2005-12-02
Substance: DEXTROSE MONOHYDRATE
Active strength: 25 g/50mL
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 1.

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 · 90 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROSE MONOHYDRATE	25 g/50mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
727517	Internal RxNorm lookup
1795514	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
4ed365da-4e62-4329-c1b9-c197ab4fb6e1	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2021-09-27	These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-09-27	These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-09-27	These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-09-27	These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23	These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23	These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23	These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
2021-07-23	These highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-7517-16	Dextrose	10 in 1 CONTAINER	INJECTION, SOLUTION	10	32
0409-7517-16	Dextrose	1 in 1 CARTON	INJECTION, SOLUTION	1	32
0409-7517-66	Dextrose	50 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	50	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-7517-16	ML - Milliliter	0409-7517	d2eecd39-de62-480a-a667-c285d8449bff	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROSE MONOHYDRATE	ACTIVE INGREDIENT	LX22YL083G	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
ANHYDROUS DEXTROSE	ACTIVE MOIETY	5SL0G7R0OK	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
DEXTROSE MONOHYDRATE	ACTIVE INGREDIENT	LX22YL083G	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	3
ANHYDROUS DEXTROSE	ACTIVE MOIETY	5SL0G7R0OK	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	3
Dextrose Monohydrate	ACTIVE INGREDIENT	LX22YL083G	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
Dextrose	ACTIVE MOIETY	IY9XDZ35W2	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-7517	DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]	28	Current NDC, Legacy NDC, 3 package rows	20250417_4ed365da-4e62-4329-c1b9-c197ab4fb6e1.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 · 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 ndc (product): 0409-7517
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
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
1795514	dextrose 50 % in 50 ML Injection	PSN	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	32
727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	32
1795514	50 ML glucose 500 MG/ML Injection	SCD	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	32
727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	32
727517	50 ML dextrose 50 % Prefilled Syringe	SY	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	32
727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	32
1795514	dextrose 50 % per 50 ML Injection	SY	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	32
727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN	8027a2bf-3019-428a-8a23-621898b5a7a3	15
727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD	8027a2bf-3019-428a-8a23-621898b5a7a3	15
727517	50 ML dextrose 50 % Prefilled Syringe	SY	8027a2bf-3019-428a-8a23-621898b5a7a3	15
727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY	8027a2bf-3019-428a-8a23-621898b5a7a3	15
727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN	8cf6943f-16e8-4521-863c-09bb0b55e2a9	6
727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD	8cf6943f-16e8-4521-863c-09bb0b55e2a9	6
727517	50 ML dextrose 50 % Prefilled Syringe	SY	8cf6943f-16e8-4521-863c-09bb0b55e2a9	6
727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY	8cf6943f-16e8-4521-863c-09bb0b55e2a9	6
727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN	763b1cb8-1151-5f59-e053-2991aa0a4e01	5
727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD	763b1cb8-1151-5f59-e053-2991aa0a4e01	5
727517	50 ML dextrose 50 % Prefilled Syringe	SY	763b1cb8-1151-5f59-e053-2991aa0a4e01	5
727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY	763b1cb8-1151-5f59-e053-2991aa0a4e01	5
727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN	b8b77421-d687-45aa-82f6-d49bce644c10	4
727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD	b8b77421-d687-45aa-82f6-d49bce644c10	4
727517	50 ML dextrose 50 % Prefilled Syringe	SY	b8b77421-d687-45aa-82f6-d49bce644c10	4
727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY	b8b77421-d687-45aa-82f6-d49bce644c10	4
727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN	66713d9c-f404-4ec8-e053-2a91aa0a620a	3
727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD	66713d9c-f404-4ec8-e053-2a91aa0a620a	3
727517	50 ML dextrose 50 % Prefilled Syringe	SY	66713d9c-f404-4ec8-e053-2a91aa0a620a	3
727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY	66713d9c-f404-4ec8-e053-2a91aa0a620a	3
727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN	3842a9c0-8b15-1c94-e063-6394a90ae120	2
727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD	3842a9c0-8b15-1c94-e063-6394a90ae120	2
727517	50 ML dextrose 50 % Prefilled Syringe	SY	3842a9c0-8b15-1c94-e063-6394a90ae120	2
727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY	3842a9c0-8b15-1c94-e063-6394a90ae120	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-7517-16	00409751716	10 CARTON in 1 CONTAINER (0409-7517-16) / 1 SYRINGE, PLASTIC in 1 CARTON / 50 mL in 1 SYRINGE, PLASTIC (0409-7517-66)	10 carton	2005-12-02	0000-00-00	No	No	Current
0409-7517-66	00409751766	50 mL in 1 SYRINGE, PLASTIC	50 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextrose	Hospira, Inc.	2026-07-13	HUMAN PRESCRIPTION DRUG LABEL	34
50% Dextrose Injection, USP	Henry Schein, Inc.	2025-10-03	HUMAN PRESCRIPTION DRUG LABEL	6
Dextrose	REMEDYREPACK INC.	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	4
50% Dextrose Injection, USP Concentrated Dextrose for Intravenous Administration	ProPharma Distribution	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	2
50% DEXTROSE INJECTION, USP 25grams (0.5g/mL) 50mL SYR	HF Acquisition Co LLC, DBA HealthFirst	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	5
50% Dextrose 0.5 gm/mL Injection, USP 50 mL PreFilled Syringe	General Injectables & Vaccines, Inc	2022-12-19	HUMAN PRESCRIPTION DRUG LABEL	13
50% Dextrose Injection, USP	Medical Purchasing Solutions, LLC	2022-10-13	HUMAN PRESCRIPTION DRUG LABEL	3
50% Dextrose Injection, USP Concentrated Dextrose for Intravenous Administration	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	15
50% Dextrose Injection, USP	Cardinal Health	2019-09-13	HUMAN PRESCRIPTION DRUG LABEL	5
50% Dextrose Injection, USP Concentrated Dextrose for Intravenous Administration	REMEDYREPACK INC.	2018-09-20	HUMAN PRESCRIPTION DRUG LABEL	1