DIANEAL Low Calcium with Dextrose
- Product NDC
- 0941-0457
- 11-digit product format
- 009410457
- Labeler code
- 0941
- Product ID
- 0941-0457_194f41a6-655b-456a-955f-7566eb429b7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAPERITONEAL
- Labeler
- Vantive US Healthcare LLC
- Application
- NDA017512
- Marketing category
- NDA
- Marketing start
- 1978-09-27
- Substance
- CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
- Active strength
- 18.3; 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017512-001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | ||
| N017512-002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | ||
| N017512-003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | ||
| N017512-004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | |
| N017512-005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | |
| N017512-006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | |
| N017512-007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | ||
| N017512-008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | ||
| N017512-009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | ||
| N017512-010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1985-11-18 | ||
| N017512-011 | DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1985-11-18 | |
| N017512-012 | DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1989-01-10 |
| N017512-013 | DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1990-07-11 |
| N017512-014 | DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1990-07-11 | |
| N017512-015 | DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1990-07-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N017512-004 | AT |
| N017512-005 | AT |
| N017512-006 | AT |
| N017512-012 | AT |
| N017512-013 | AT |
| N017512-015 | 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.
| 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 | N017512-001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1985-11-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-011 | DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1985-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-012 | DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1989-01-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-013 | DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1990-07-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-014 | DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1990-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-015 | DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1990-07-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1985-11-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-011 | DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1985-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-012 | DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1989-01-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-013 | DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1990-07-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-014 | DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1990-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-015 | DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1990-07-11 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1985-11-18 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N017512-004 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-005 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-006 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-012 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-013 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-015 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-004 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-005 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-006 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-012 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-013 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-015 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-004 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-005 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-006 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-012 | AT | 1 | 6a471c1ec25d… |
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| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-004 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-005 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-006 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-012 | AT | 1 | fd3edfee7708… |
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| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017512-004 | AT | 1 | b8a1b40f171c… |
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| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-004 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-005 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-006 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-012 | AT | 1 | 03ed91905a0d… |
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| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-015 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017512-004 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017512-005 | AT | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DIANEAL Low Calcium with Dextrose
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROSE MONOHYDRATE | 18.3 mg/100mL |
| SODIUM CHLORIDE | 2.5 g/100mL |
| SODIUM LACTATE | 5.08 mg/100mL |
| CALCIUM CHLORIDE | 538 mg/100mL |
| MAGNESIUM CHLORIDE | 448 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LX22YL083G | Internal UNII lookup |
| 02F3473H9O | Internal UNII lookup |
| M4I0D6VV5M | Internal UNII lookup |
| 451W47IQ8X | Internal UNII lookup |
| TU7HW0W0QT | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 799999 | Internal RxNorm lookup |
| 800003 | Internal RxNorm lookup |
| 800057 | Internal RxNorm lookup |
| 800061 | Internal RxNorm lookup |
| 800062 | Internal RxNorm lookup |
| 800064 | Internal RxNorm lookup |
| 800066 | Internal RxNorm lookup |
| 800074 | Internal RxNorm lookup |
| 800111 | Internal RxNorm lookup |
| 800115 | Internal RxNorm lookup |
| 800472 | Internal RxNorm lookup |
| 800474 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aa268d3f-7389-4f25-801f-5d4825495f08 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0941-0457-01 | DIANEAL Low Calcium with Dextrose | 6000 mL in 1 BAG | INJECTION, SOLUTION | 6000 | 37 | |
| 0941-0457-02 | DIANEAL Low Calcium with Dextrose | 3000 mL in 1 BAG | INJECTION, SOLUTION | 3000 | 37 | |
| 0941-0457-05 | DIANEAL Low Calcium with Dextrose | 5000 mL in 1 BAG | INJECTION, SOLUTION | 5000 | 37 | |
| 0941-0457-08 | DIANEAL Low Calcium with Dextrose | 2000 mL in 1 BAG | INJECTION, SOLUTION | 2000 | 37 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0941-0457-01 | ML - Milliliter | 0941-0457 | 78d3c231-c764-4368-aa12-eda7328d1cc4 | 1 | 2012-07-24 |
| 0941-0457-02 | ML - Milliliter | 0941-0457 | 772b1558-d81b-474d-9fd9-48fd077fe0d0 | 1 | 2012-07-24 |
| 0941-0457-05 | ML - Milliliter | 0941-0457 | 897f5c74-6fbd-44d0-a02f-694f14ba49d8 | 1 | 2012-07-24 |
| 0941-0457-08 | ML - Milliliter | 0941-0457 | 38024003-d177-412e-ae77-bd3b89e22ae7 | 1 | 2012-07-24 |
| 0941-0457-25 | ML - Milliliter | 0941-0457 | ec1bb26e-ee92-487d-8d82-b17591eacbb8 | 1 | 2012-07-24 |
| 0941-0457-28 | ML - Milliliter | 0941-0457 | 409ebc0c-e243-42b8-8219-d3b448dc2b46 | 1 | 2012-07-24 |
| 0941-0457-47 | ML - Milliliter | 0941-0457 | f6f7adba-9981-4b8e-8a21-7a1d6c9ded53 | 1 | 2012-07-24 |
| 0941-0457-49 | ML - Milliliter | 0941-0457 | 81736bb3-acf6-4c1f-8e1b-01c7e8c9e27f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0941-0457 | DIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC] | 34 | Current NDC, Legacy NDC, 4 package rows | 20250425_aa268d3f-7389-4f25-801f-5d4825495f08.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DIANEAL Low Calcium with Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | aa268d3f-7389-4f25-801f-5d4825495f08 | 2026-04-16 | Warnings, Adverse reactions | 017512 NDA017512 0941-0457 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 800064 | Dianeal PD-2/2.5 Intraperitoneal Solution | PSN | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800061 | calcium chloride 0.00014 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/1.5] | SBD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800064 | calcium chloride 0.00014 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/2.5] | SBD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800003 | calcium chloride 0.00014 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/4.25] | SBD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800474 | calcium chloride 0.000996 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 1.5] | SBD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800115 | calcium chloride 0.000996 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 2.5] | SBD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800074 | calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25] | SBD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800057 | calcium chloride 0.00014 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution | SCD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800062 | calcium chloride 0.00014 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution | SCD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 799999 | calcium chloride 0.00014 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution | SCD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800472 | calcium chloride 0.000996 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution | SCD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800111 | calcium chloride 0.000996 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution | SCD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800066 | calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution | SCD | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800057 | Calcium Chloride 0.00014 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800061 | Calcium Chloride 0.00014 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/1.5] | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800062 | Calcium Chloride 0.00014 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800064 | Calcium Chloride 0.00014 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/2.5] | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 799999 | Calcium Chloride 0.00014 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800003 | Calcium Chloride 0.00014 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/4.25] | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800472 | Calcium Chloride 0.000996 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800474 | Calcium Chloride 0.000996 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 1.5] | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800111 | Calcium Chloride 0.000996 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800115 | Calcium Chloride 0.000996 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 2.5] | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800066 | Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800074 | Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25] | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800474 | Dianeal Low Calcium 1.5 % Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800115 | Dianeal Low Calcium 2.5 % Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800074 | Dianeal Low Calcium 4.25 % Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800061 | Dianeal PD-2/1.5 2500 ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800064 | Dianeal PD-2/2.5 2500 ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
| 800003 | Dianeal PD-2/4.25 2500 ML Intraperitoneal Solution | SY | aa268d3f-7389-4f25-801f-5d4825495f08 | 37 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0941-0457-01 | 00941045701 | 6000 mL in 1 BAG (0941-0457-01) | 6000 ml | 1978-09-27 | 0000-00-00 | No | No | Current |
| 0941-0457-02 | 00941045702 | 3000 mL in 1 BAG (0941-0457-02) | 3000 ml | 1978-09-27 | 0000-00-00 | No | No | Current |
| 0941-0457-05 | 00941045705 | 5000 mL in 1 BAG (0941-0457-05) | 5000 ml | 1978-09-27 | 0000-00-00 | No | No | Current |
| 0941-0457-08 | 00941045708 | 2000 mL in 1 BAG (0941-0457-08) | 2000 ml | 1978-09-27 | 0000-00-00 | No | No | Current |