DELFLEX

Product NDC: 49230-209
Requested package NDC: 49230-209-94
11-digit product format: 492300209
Labeler code: 49230
Product ID: 49230-209_43cd31e0-97ed-1eeb-e063-6294a90a0b3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
Dosage form: SOLUTION
Route: INTRAPERITONEAL
Labeler: Fresenius Medical Care Renal Therapies Group, LLC
Application: NDA020171
Marketing category: NDA
Marketing start: 1992-08-19
Substance: CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength: 18.4; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes: Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 1.

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
N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19
N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19
N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020171-001	AT
N020171-002	AT
N020171-003	AT

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 · 123 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	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020171-002	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020171-003	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020171-001	DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTION / INTRAPERITONEAL	AT	RLD, RS	1992-08-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020171-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020171-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020171-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020171-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020171-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020171-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020171-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020171-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020171-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020171-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020171-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020171-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020171-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020171-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020171-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020171-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020171-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020171-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020171-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020171-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020171-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020171-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020171-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020171-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020171-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020171-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020171-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020171-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020171-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020171-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020171-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020171-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020171-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020171-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020171-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020171-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020171-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020171-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020171-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020171-001	AT	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: DELFLEX
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM CHLORIDE	18.4 mg/100mL
SODIUM LACTATE	2.5 g/100mL
CALCIUM CHLORIDE	5.08 mg/100mL
MAGNESIUM CHLORIDE	538 mg/100mL
DEXTROSE MONOHYDRATE	448 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
02F3473H9O	Internal UNII lookup
TU7HW0W0QT	Internal UNII lookup
LX22YL083G	Internal UNII lookup
451W47IQ8X	Internal UNII lookup
M4I0D6VV5M	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bbc5b820-4973-11e2-a192-0002a5d5c51b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49230-209-23	DELFLEX	2000 mL in 1 BAG	SOLUTION	2000	36
49230-209-23	DELFLEX	6 in 1 CARTON	SOLUTION	6	36
49230-209-30	DELFLEX	3000 mL in 1 BAG	SOLUTION	3000	36
49230-209-30	DELFLEX	4 in 1 CARTON	SOLUTION	4	36
49230-209-32	DELFLEX	4 in 1 CARTON	SOLUTION	4	36
49230-209-32	DELFLEX	3000 mL in 1 BAG	SOLUTION	3000	36
49230-209-50	DELFLEX	5000 mL in 1 BAG	SOLUTION	5000	36
49230-209-50	DELFLEX	2 in 1 CARTON	SOLUTION	2	36
49230-209-52	DELFLEX	5000 mL in 1 BAG	SOLUTION	5000	36
49230-209-52	DELFLEX	2 in 1 CARTON	SOLUTION	2	36
49230-209-60	DELFLEX	6000 mL in 1 BAG	SOLUTION	6000	36
49230-209-60	DELFLEX	2 in 1 CARTON	SOLUTION	2	36
49230-209-62	DELFLEX	6000 mL in 1 BAG	SOLUTION	6000	36
49230-209-62	DELFLEX	2 in 1 CARTON	SOLUTION	2	36
49230-209-92	DELFLEX	2000 mL in 1 BAG	SOLUTION	2000	24
49230-209-92	DELFLEX	5 in 1 CARTON	SOLUTION	5	24
49230-209-94	DELFLEX	2500 mL in 1 BAG	SOLUTION	2500	24
49230-209-94	DELFLEX	5 in 1 CARTON	SOLUTION	5	24
49230-209-95	DELFLEX	3000 mL in 1 BAG	SOLUTION	3000	24
49230-209-95	DELFLEX	4 in 1 CARTON	SOLUTION	4	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49230-209-15	ML - Milliliter	49230-209	3f64697e-b010-401a-b297-0d3c938b68e7	1	2013-02-13
49230-209-23	ML - Milliliter	49230-209	86afc1b8-6c83-4228-ba3c-ee7497b604df	1	2022-02-07
49230-209-25	ML - Milliliter	49230-209	f68383a9-934a-4dae-bf24-3637c761703b	1	2013-02-13
49230-209-30	ML - Milliliter	49230-209	8c3df1a4-9c7a-44bb-af5f-0a61edd6dcc3	1	2013-02-13
49230-209-50	ML - Milliliter	49230-209	59d27114-68b9-40da-8e56-c947effa63a3	1	2013-02-13
49230-209-91	ML - Milliliter	49230-209	1279e2a4-a9a3-43e6-bd2a-047bd6cab98d	1	2013-02-13
49230-209-92	ML - Milliliter	49230-209	d9d3a093-5f0e-4129-ac77-f02e2c3d6c2a	1	2013-02-13
49230-209-94	ML - Milliliter	49230-209	65e82486-12bc-41de-8650-0ec26b7f45d2	1	2013-02-13
49230-209-95	ML - Milliliter	49230-209	676c800b-46e8-4dcf-8f69-a66d8b7a3960	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM CHLORIDE	ACTIVE INGREDIENT	M4I0D6VV5M	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
CALCIUM CHLORIDE	ACTIVE INGREDIENT	M4I0D6VV5M	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
DEXTROSE MONOHYDRATE	ACTIVE INGREDIENT	LX22YL083G	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
DEXTROSE MONOHYDRATE	ACTIVE INGREDIENT	LX22YL083G	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
MAGNESIUM CHLORIDE	ACTIVE INGREDIENT	02F3473H9O	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
MAGNESIUM CHLORIDE	ACTIVE INGREDIENT	02F3473H9O	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
SODIUM LACTATE	ACTIVE INGREDIENT	TU7HW0W0QT	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
SODIUM LACTATE	ACTIVE INGREDIENT	TU7HW0W0QT	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
ANHYDROUS DEXTROSE	ACTIVE MOIETY	5SL0G7R0OK	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
ANHYDROUS DEXTROSE	ACTIVE MOIETY	5SL0G7R0OK	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
LACTIC ACID	ACTIVE MOIETY	33X04XA5AT	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
LACTIC ACID	ACTIVE MOIETY	33X04XA5AT	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
Water	INACTIVE INGREDIENT	059QF0KO0R	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7
Water	INACTIVE INGREDIENT	059QF0KO0R	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49230-209	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	33	Current NDC, Legacy NDC, 14 package rows	20241215_bbc5b820-4973-11e2-a192-0002a5d5c51b.zip
49230-209	DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	21	Current NDC, Legacy NDC, 6 package rows	20241215_c29bdfa0-4976-11e2-939b-0002a5d5c51b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DELFLEX	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Fresenius Medical Care Renal Therapies Group, LLC	bbc5b820-4973-11e2-a192-0002a5d5c51b	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020171 application number: NDA020171 ndc (product): 49230-209
DELFLEX	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Fresenius Medical Care Renal Therapies Group, LLC	c29bdfa0-4976-11e2-939b-0002a5d5c51b	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020171 application number: NDA020171 ndc (package): 49230-209-94 ndc (product): 49230-209 ndc11 (package): 49230020994
Delflex	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Fresenius Medical Care de Mexico, S.A. de C.V.	a98facd6-9daa-4d37-8209-63a0599dbfaa	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020171 application number: NDA020171

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M4I0D6VV5M	CALCIUM CHLORIDE	10035-04-8	CALCIUM CHLORIDE
LX22YL083G	DEXTROSE MONOHYDRATE	77938-63-7	DEXTROSE MONOHYDRATE
02F3473H9O	MAGNESIUM CHLORIDE	7791-18-6	MAGNESIUM CHLORIDE
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
TU7HW0W0QT	SODIUM LACTATE	72-17-3	SODIUM LACTATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49230-209-94	49230020994	5 BAG in 1 CARTON (49230-209-94) / 2500 mL in 1 BAG	5 bag	1992-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DELFLEX	Fresenius Medical Care Renal Therapies Group, LLC	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	37
DELFLEX	Fresenius Medical Care Renal Therapies Group, LLC	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	25