LACTULOSE
- Product NDC
- 85592-819
- 11-digit product format
- 855920819
- Labeler code
- 85592
- Product ID
- 85592-819_ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lactulose
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Cumberland Assured Products Inc.
- Application
- ANDA074712
- Marketing category
- ANDA
- Marketing start
- 2025-09-01
- Substance
- LACTULOSE
- Active strength
- 10 g/10g
- Pharmacologic classes
- Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [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
- LACTULOSE
- Brand name suffix
- Crystalline
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LACTULOSE | 10 g/10g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9U7D5QH5AE |
| Rxcui | 1251190, 1251194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85592-819-01 | LACTULOSE Crystalline | 10 g in 1 POUCH | POWDER, FOR SOLUTION | 10 | | 2 |
| 85592-819-30 | LACTULOSE Crystalline | 30 in 1 CARTON | POWDER, FOR SOLUTION | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85592-819-01 | 85592081901 | 10 g in 1 POUCH | 10 g | | | | Historical |
| 85592-819-30 | 85592081930 | 30 POUCH in 1 CARTON (85592-819-30) / 10 g in 1 POUCH (85592-819-01) | 30 pouch | 2025-09-01 | No | No | Current |