Elliotts B
- Product NDC
- 55792-007
- 11-digit product format
- 557920007
- Labeler code
- 55792
- Product ID
- 55792-007_4a638cd1-6922-477a-aa17-a70865ae0bd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate
- Dosage form
- INJECTION
- Route
- INTRATHECAL
- Labeler
- Lukare Medical, LLC
- Application
- NDA020577
- Marketing category
- NDA
- Marketing start
- 2013-06-04
- Substance
- ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
- Active strength
- 8; 2; 3; 3; 19; 73; 2 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL
- Pharmacologic classes
- Alkalinizing Activity [MoA], 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], 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
- Elliotts B
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ANHYDROUS DEXTROSE | 8 mg/10mL |
| CALCIUM CHLORIDE | 2 mg/10mL |
| MAGNESIUM SULFATE, UNSPECIFIED FORM | 3 mg/10mL |
| POTASSIUM CHLORIDE | 3 mg/10mL |
| SODIUM BICARBONATE | 19 mg/10mL |
| SODIUM CHLORIDE | 73 mg/10mL |
| SODIUM PHOSPHATE | 2 mg/10mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 5SL0G7R0OK, M4I0D6VV5M, DE08037SAB, 660YQ98I10, 8MDF5V39QO, 451W47IQ8X, SE337SVY37 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55792-007-01 | Elliotts B | 10 mL in 1 AMPULE | INJECTION | 10 | 6 | |
| 55792-007-10 | Elliotts B | 10 in 1 BOX | INJECTION | 10 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55792-007-01 | ML - Milliliter | 55792-007 | 45675f1d-bf1f-4d54-be81-4f0c1cc9b517 | 1 | 2019-08-06 |
| 55792-007-10 | ML - Milliliter | 55792-007 | bdcae154-55aa-42ee-9f20-636d670a1376 | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55792-007 | ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241018_08036dbd-55b3-47b9-9890-000f253544f3.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55792-007-01 | 55792000701 | 10 mL in 1 AMPULE | 10 ml | Historical | ||||
| 55792-007-10 | 55792000710 | 10 AMPULE in 1 BOX (55792-007-10) / 10 mL in 1 AMPULE (55792-007-01) | 10 ampule | 2013-06-04 | 0000-00-00 | No | No | Current |