Dextrose

Product NDC: 84549-460
11-digit product format: 845490460
Labeler code: 84549
Product ID: 84549-460_3eff8bcd-6a32-428f-e063-6394a90afa68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextrose Monohydrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: ProPharma Distribution
Application: ANDA207449
Marketing category: ANDA
Marketing start: 2024-07-09
Substance: DEXTROSE MONOHYDRATE
Active strength: 50 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE / INJECTION	AP		2016-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207449-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207449-001	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	2016-10-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A207449-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207449-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207449-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207449-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207449-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207449-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207449-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207449-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207449-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207449-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207449-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207449-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207449-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207449-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207449-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207449-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207449-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207449-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207449-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207449-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207449-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207449-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207449-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207449-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207449-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207449-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207449-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207449-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207449-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207449-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207449-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207449-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207449-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207449-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207449-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207449-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207449-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207449-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207449-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207449-001	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROSE MONOHYDRATE	50 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
1795607	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
3eff8bcd-6a33-428f-e063-6394a90afa68	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
84549-460-20	Dextrose	500 mL in 1 BAG	INJECTION, SOLUTION	500		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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose	DEXTROSE MONOHYDRATE	BECTON DICKINSON AND COMPANY	32132016-1870-481b-9816-e11beb03ca0b	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207449 application number: ANDA207449
Dextrose	DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	bd250a46-d229-4e80-b5a1-b34169ccecc4	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207449 application number: ANDA207449
Dextrose	DEXTROSE MONOHYDRATE	ProPharma Distribution	3eff8bcd-6a33-428f-e063-6394a90afa68	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207449 application number: ANDA207449 ndc (product): 84549-460
Dextrose	DEXTROSE MONOHYDRATE	FRESENIUS KABI USA, LLC	576a22d8-5f2f-497e-80ad-1842ca74bb53	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207449 application number: ANDA207449
Dextrose	DEXTROSE MONOHYDRATE	Becton Dickinson and Company	c1f72bce-4bef-49db-a8da-f26a703d6748	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207449 application number: ANDA207449
Dextrose	DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	f2379398-a07b-417e-a022-f7b41f962067	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207449 application number: ANDA207449

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
1795607	dextrose 5 % in 500 ML Injection	PSN	3eff8bcd-6a33-428f-e063-6394a90afa68	1
1795607	500 ML glucose 50 MG/ML Injection	SCD	3eff8bcd-6a33-428f-e063-6394a90afa68	1
1795607	dextrose 5 % per 500 ML Injection	SY	3eff8bcd-6a33-428f-e063-6394a90afa68	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-460-20	84549046020	500 mL in 1 BAG (84549-460-20)	500 ml	2025-09-17	No	No	Current