Lactulose
- Product NDC
- 68999-004
- 11-digit product format
- 689990004
- Labeler code
- 68999
- Product ID
- 68999-004_437b8b21-3264-1b6c-e063-6294a90a1d51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell Governmental & Specialty RX, LLC.
- Application
- ANDA209517
- Marketing category
- ANDA
- Marketing start
- 2018-11-23
- Substance
- LACTULOSE
- Active strength
- 20 g/30mL
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LACTULOSE | 20 g/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9U7D5QH5AE |
| Rxcui | 391937 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68999-004-24 | Lactulose | 10 in 1 TRAY | SOLUTION | 10 | | 1 |
| 68999-004-24 | Lactulose | 2 in 1 BOX | SOLUTION | 2 | | 1 |
| 68999-004-43 | Lactulose | 30 mL in 1 CUP, UNIT-DOSE | SOLUTION | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68999-004-24 | 68999000424 | 2 TRAY in 1 BOX (68999-004-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (68999-004-43) | 2 tray | 2025-10-29 | No | No | Historical |
| 68999-004-43 | 68999000443 | 30 mL in 1 CUP, UNIT-DOSE | 30 ml | | | | Historical |