Balanced Salt
- Product NDC
- 0264-1945
- 11-digit product format
- 002641945
- Labeler code
- 0264
- Product ID
- 0264-1945_e2d4babc-3f0e-454c-ba77-e2f82fddff51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate
- Dosage form
- SOLUTION
- Route
- IRRIGATION
- Labeler
- B. Braun Medical Inc.
- Application
- ANDA091387
- Marketing category
- ANDA
- Marketing start
- 2022-01-28
- Substance
- CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
- Active strength
- .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
- 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], 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 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 Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Balanced Salt
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CALCIUM CHLORIDE | .48 mg/mL |
| MAGNESIUM CHLORIDE | .3 mg/mL |
| POTASSIUM CHLORIDE | .75 mg/mL |
| SODIUM ACETATE | 3.9 mg/mL |
| SODIUM CHLORIDE | 6.4 mg/mL |
| SODIUM CITRATE | 1.7 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | M4I0D6VV5M, 02F3473H9O, 660YQ98I10, 4550K0SC9B, 451W47IQ8X, 1Q73Q2JULR |
| Rxcui | 806392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0264-1945-10 | Balanced Salt | 500 mL in 1 BAG | SOLUTION | 500 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0264-1945 | BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240316_74ab8883-0a5f-46b4-8998-9358f6fd4ef4.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 806392 | calcium chloride 0.048 % / magnesium chloride 0.03 % / potassium chloride 0.075 % / sodium acetate 0.39 % / sodium chloride 0.64 % / sodium citrate 0.17 % Ophthalmic Solution | PSN | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | 2 |
| 806392 | calcium chloride 0.004 MEQ/ML / magnesium chloride 0.003 MEQ/ML / potassium chloride 0.01 MEQ/ML / sodium acetate 0.0475 MEQ/ML / sodium chloride 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution | SCD | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | 2 |
| 806392 | Calcium Chloride 0.004 MEQ/ML / Magnesium Chloride 0.003 MEQ/ML / K+ Chloride 0.01 MEQ/ML / Sodium Acetate 0.0475 MEQ/ML / NaCl 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution | SY | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | 2 |
| 806392 | Calcium Chloride 0.004 MEQ/ML / Magnesium Chloride 0.003 MEQ/ML / Pot Chloride 0.01 MEQ/ML / Sodium Acetate 0.0475 MEQ/ML / NaCl 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution | SY | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | 2 |
| 806392 | calcium chloride 0.048 % / magnesium chloride 0.03 % / potassium chloride 0.075 % / sodium acetate 0.39 % / sodium chloride 0.64 % / sodium citrate 0.17 % Ophthalmic Solution | SY | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0264-1945-10 | 00264194510 | 500 mL in 1 BAG (0264-1945-10) | 500 ml | 2022-01-28 | 0000-00-00 | No | No | Current |