Physiolyte
- Product NDC
- 0264-2205
- 11-digit product format
- 002642205
- Labeler code
- 0264
- Product ID
- 0264-2205_03ced4e7-7317-45fb-8303-54a924c7d281
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride
- Dosage form
- IRRIGANT
- Route
- IRRIGATION
- Labeler
- B. Braun Medical Inc.
- Application
- NDA019024
- Marketing category
- NDA
- Marketing start
- 1984-06-08
- Substance
- MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
- Active strength
- .03; .037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], 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], 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
- Physiolyte
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MAGNESIUM CHLORIDE | .03 g/100mL |
| POTASSIUM CHLORIDE | .037 g/100mL |
| SODIUM ACETATE | .37 g/100mL |
| SODIUM CHLORIDE | .53 g/100mL |
| SODIUM GLUCONATE | .5 g/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 02F3473H9O, 660YQ98I10, 4550K0SC9B, 451W47IQ8X, R6Q3791S76 |
| Rxcui | 827351, 827353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0264-2205-00 | Physiolyte | 1000 mL in 1 CONTAINER | IRRIGANT | 1000 | 7 | |
| 0264-2205-00 | Physiolyte | 16 in 1 CASE | IRRIGANT | 16 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0264-2205-00 | ML - Milliliter | 0264-2205 | 993b6d9d-32ff-4b24-a7ca-78ab51d92438 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0264-2205 | PHYSIOLYTE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [B. BRAUN MEDICAL INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230927_19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 827351 | magnesium chloride 0.03 GM / potassium chloride 0.037 GM / sodium acetate 0.37 GM / sodium chloride 0.53 GM / sodium gluconate 0.5 GM in 100 mL Irrigation Solution | PSN | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Physiolyte 0.03 GM / 0.037 GM / 0.37 GM / 0.53 GM / 0.5 GM in 100 mL Irrigation Solution | PSN | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.005 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.09 MEQ/ML / sodium gluconate 0.023 MEQ/ML Irrigation Solution [Physiolyte] | SBD | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827351 | magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.005 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.09 MEQ/ML / sodium gluconate 0.023 MEQ/ML Irrigation Solution | SCD | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827351 | Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution [Physiolyte] | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827351 | Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution [Physiolyte] | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827351 | magnesium chloride 0.03 GM / potassium chloride 0.037 GM / sodium acetate 0.37 GM / sodium chloride 0.53 GM / sodium gluconate 0.5 GM per 100 ML Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Physiolyte (magnesium chloride 0.03 GM / potassium chloride 0.037 GM / sodium acetate 0.37 GM / sodium chloride 0.53 GM / sodium gluconate 0.5 GM per 100 ML) Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Physiolyte Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0264-2205-00 | 00264220500 | 16 CONTAINER in 1 CASE (0264-2205-00) / 1000 mL in 1 CONTAINER | 16 container | 1984-06-08 | 0000-00-00 | No | No | Current |