Application 019631

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;110MG/100ML	No	No
002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;200MG/100ML	No	No
003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;330MG/100ML	No	No
004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	No	No
005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;900MG/100ML	No	No
006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;110MG/100ML	No	No
007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;200MG/100ML	No	No
008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;330MG/100ML	No	No
009	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	No	No
010	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;900MG/100ML	No	No
011	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;110MG/100ML	No	No
012	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;200MG/100ML	No	No
013	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;330MG/100ML	No	No
014	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;450MG/100ML	No	No
015	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	10GM/100ML;900MG/100ML	No	No
016	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.3GM/100ML;300MG/100ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 16 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N019631-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-009	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-010	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24
N019631-011	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-012	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-013	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-014	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;450MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-015	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	10GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24
N019631-016	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	3.3GM/100ML;300MG/100ML	INJECTABLE / INJECTION		1990-01-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N019631-004	AP
N019631-007	AP
N019631-008	AP
N019631-009	AP
N019631-010	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 17 · 672 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	N019631-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	2.5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	2.5GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	2.5GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	2.5GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-009	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-010	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	5GM/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-011	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	10GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-012	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	10GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-013	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	10GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-014	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10GM/100ML;450MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-015	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	10GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-016	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	3.3GM/100ML;300MG/100ML	INJECTABLE / INJECTION		1990-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019631-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	2.5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	2.5GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	2.5GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	2.5GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-009	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-010	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	5GM/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-011	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	10GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-012	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	10GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-013	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	10GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-014	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10GM/100ML;450MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-015	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	10GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-016	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	3.3GM/100ML;300MG/100ML	INJECTABLE / INJECTION		1990-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	2.5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-002	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	2.5GM/100ML;200MG/100ML	INJECTABLE / INJECTION		1988-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-003	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	2.5GM/100ML;330MG/100ML	INJECTABLE / INJECTION		1988-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-004	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-005	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	2.5GM/100ML;900MG/100ML	INJECTABLE / INJECTION		1988-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-006	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION		1988-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-007	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-008	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1988-02-24	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	N019631-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-009	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019631-010	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019631-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-009	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019631-010	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-009	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019631-010	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019631-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019631-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019631-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019631-009	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019631-010	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-008	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-009	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019631-010	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-007	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-008	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-009	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019631-010	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019631-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019631-007	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019631-008	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019631-009	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019631-010	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019631-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019631-007	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019631-008	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019631-009	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019631-010	AP	1	`2680178bc6a6…`

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 And Sodium Chloride	DEXTROSE AND SODIUM CHLORIDE	B. Braun Medical Inc.	8e6569ce-9714-497f-a94b-c6975c1d76f6	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019631 application number: NDA019631 ndc (product): 0264-7605 ndc (product): 0264-7614 ndc (product): 0264-7612 ndc (product): 0264-7622 ndc (product): 0264-7610 ndc (product): 0264-7616 ndc (product): 0264-7608 ndc (product): 0264-7623

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-7605	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7608	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7608	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7610	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7610	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7612	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7612	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7614	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7614	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7616	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7616	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7622	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7622	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7623	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7623	Dextrose And Sodium Chloride	DEXTROSE and SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33817	SUPPL	2004-09-29
17494	SUPPL	2004-09-29