Application 020179

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	5GM/100ML	Yes	Yes
002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	50MG/ML	Yes	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
N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07
N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020179-001	AP
N020179-002	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 · 84 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	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020179-001	DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020179-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`bb7c543d1eb4…`

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	N020179-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020179-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020179-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020179-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020179-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020179-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020179-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020179-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020179-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020179-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020179-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020179-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020179-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020179-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020179-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020179-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020179-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020179-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020179-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020179-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020179-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020179-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020179-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020179-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020179-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020179-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020179-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020179-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020179-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020179-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020179-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020179-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020179-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020179-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020179-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020179-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020179-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020179-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020179-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020179-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose	DEXTROSE MONOHYDRATE	Baxter Healthcare Company	bfc4224a-2fc9-4137-b4c6-9d2d6d948413	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020179 application number: NDA020179
Dextrose	DEXTROSE MONOHYDRATE	Baxter Healthcare Company	9c80dfee-8923-4d1f-85b0-98bd68b94212	2022-12-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020179 application number: NDA020179 ndc (product): 0338-0174 ndc (product): 0338-0176 ndc (product): 0338-0172 ndc (product): 0338-0170
Dextrose	DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	50603082-bce5-49eb-9737-e04239cfb695	2022-12-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020179 application number: NDA020179 ndc (product): 0338-0211 ndc (product): 0338-0204 ndc (product): 0338-0208 ndc (product): 0338-0216
Dextrose	DEXTROSE MONOHYDRATE	Baxter Healthcare Company	0bfb32b2-d034-4219-a055-3448f0c424f7	2021-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020179 application number: NDA020179 ndc (product): 0338-9143 ndc (product): 0338-9147
Dextrose	DEXTROSE MONOHYDRATE	Baxter Healthcare Company	7de48bdb-9a05-4f2a-bbff-dcfeb284ca6e	2020-02-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020179 application number: NDA020179 ndc (product): 0338-0551

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0170	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0172	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0174	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0176	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0204	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0208	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0211	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0216	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0551	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0551	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0551	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0551	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0551	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0551	Dextrose	Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9143	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9143	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9143	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9143	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9143	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9143	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-9147	Dextrose	dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72824	SUPPL	2022-12-08
59726	SUPPL	2019-08-15
59602	SUPPL	2019-08-06
59587	SUPPL	2019-08-05