Lactulose
- Product NDC
- 51672-4243
- 11-digit product format
- 516724243
- Labeler code
- 51672
- Product ID
- 51672-4243_3b8ff35a-8b5e-7aca-e063-6394a90aea34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA218858
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- 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 |
|---|
| 51672-4243-9 | Lactulose | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 51672-4243-9 | 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 |
|---|
| 51672-4243 | LACTULOSE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 2 | Current NDC, 2 package rows | 20250412_391cfd01-c1fa-41f9-abd7-d0abe9a27634.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51672-4243-9 | 51672424309 | 1 BOTTLE in 1 CARTON (51672-4243-9) / 473 mL in 1 BOTTLE | 1 bottle | 2025-06-02 | No | No | Current |