Application 020047

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 50% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	50GM/100ML	Yes	Yes
002	DEXTROSE 60% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	60GM/100ML	No	No
003	DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	70GM/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020047-002	DEXTROSE 60% IN PLASTIC CONTAINER	60GM/100ML	INJECTABLE / INJECTION			1991-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020047-003	DEXTROSE 70% IN PLASTIC CONTAINER	70GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020047-001	DEXTROSE 50% IN PLASTIC CONTAINER	50GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-07-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	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…`
2022-03-09 01:35 UTC	2022-03	N020047-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020047-003	AP	1	`bb7c543d1eb4…`

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 (product): 0338-0719

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0719	DEXTROSE	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0719	DEXTROSE	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0719	DEXTROSE	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0719	DEXTROSE	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0719	DEXTROSE	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0719	DEXTROSE	Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59601	SUPPL	2019-08-06
59586	SUPPL	2019-08-06
12161	SUPPL	2015-01-09
1949	SUPPL	2014-12-24