Lactulose
- Product NDC
- 18124-002
- 11-digit product format
- 181240002
- Labeler code
- 18124
- Product ID
- 18124-002_d95ab755-1c2e-4124-8ed7-075936257c25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose
- Dosage form
- SOLUTION
- Route
- ORAL; RECTAL
- Labeler
- Fresenius Kabi Austria GmbH
- Application
- ANDA090502
- Marketing category
- ANDA
- Marketing start
- 2012-12-10
- Substance
- LACTULOSE
- Active strength
- 10 g/15mL
- 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 | 10 g/15mL |
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 |
|---|
| 18124-002-16 | Lactulose | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 18124-002 | LACTULOSE (LACTULOSE) SOLUTION [FRESENIUS KABI AUSTRIA GMBH] | 5 | Current NDC, Legacy NDC, 1 package rows | 20221112_a89835c9-8ce5-4627-8d7d-70ff175b2e07.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 18124-002-16 | 18124000216 | 473 mL in 1 BOTTLE (18124-002-16) | 473 ml | 2012-12-10 | 0000-00-00 | No | No | Current |