SUPREP Bowel Prep
- Product NDC
- 52268-112
- 11-digit product format
- 522680112
- Labeler code
- 52268
- Product ID
- 52268-112_9e639746-efc2-429f-b6c3-4d20a5f1a928
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium sulfate, potassium sulfate, magnesium sulfate
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- Braintree Laboratories, Inc.
- Application
- NDA022372
- Marketing category
- NDA
- Marketing start
- 2010-08-05
- Substance
- MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM SULFATE; SODIUM SULFATE
- Active strength
- 1.2; 2.35; 13.13 g/133.1mL; g/133.1mL; g/133.1mL
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], 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], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SUPREP Bowel Prep
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MAGNESIUM SULFATE, UNSPECIFIED FORM | 1.2 g/133.1mL |
| POTASSIUM SULFATE | 2.35 g/133.1mL |
| SODIUM SULFATE | 13.13 g/133.1mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | DE08037SAB, 1K573LC5TV, 0YPR65R21J |
| Rxcui | 1001689, 1001690, 1120068, 2390767, 2390768 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52268-112-01 | SUPREP Bowel Prep | 133.1 mL in 1 BOTTLE, PLASTIC | SOLUTION, CONCENTRATE | 133.1 | 9 | |
| 52268-112-01 | SUPREP Bowel Prep | 2 in 1 CARTON | SOLUTION, CONCENTRATE | 2 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52268-112 | SUPREP BOWEL PREP (SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE) SOLUTION, CONCENTRATE [BRAINTREE LABORATORIES, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20200820_2f5f06de-ee98-44c0-be7e-9a998d1e5c16.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2390768 | {2 (355 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack [Suprep Pediatric Bowel Prep Kit] | BPCK | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1001690 | {2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack [Suprep Bowel Prep Kit] | BPCK | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 2390767 | {2 (355 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack | GPCK | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1001689 | {2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack | GPCK | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 2390767 | {2 (12 OZ magnesium sulfate 1.2 GM / potassium sulfate 2.35 GM / sodium sulfate 13.13 GM Oral Solution) } Pack | PSN | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1001689 | 2 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) Pack | PSN | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1120068 | magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM in 177 mL Oral Solution | PSN | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1001690 | SUPREP BOWEL PREP KIT | PSN | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 2390768 | SUPREP PEDIATRIC BOWEL PREP KIT | PSN | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1120068 | magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution | SCD | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 2390768 | {2 (12 OZ magnesium sulfate 1.2 GM / potassium sulfate 2.35 GM / sodium sulfate 13.13 GM Oral Solution) } Pack [Suprep Bowel Prep Kit] | SY | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1001690 | {2 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) } Pack [Suprep Bowel Prep Kit] | SY | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1120068 | Magnesium Sulfate 0.0277 MEQ/ML / K+ sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution | SY | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1120068 | Magnesium Sulfate 0.0277 MEQ/ML / Pot sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution | SY | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1120068 | magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM per 177 ML Oral Solution | SY | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 1001690 | Suprep Bowel Prep Kit | SY | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
| 2390768 | Suprep Pediatric Bowel Prep Kit | SY | 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52268-112-01 | 52268011201 | 2 BOTTLE, PLASTIC in 1 CARTON (52268-112-01) / 133.1 mL in 1 BOTTLE, PLASTIC | 2021-01-05 | 0000-00-00 | No | No | Current |