Lactulose
- Product NDC
- 50383-779
- 11-digit product format
- 503830779
- Labeler code
- 50383
- Product ID
- 50383-779_9e355a5d-ef2c-4c39-b511-fd9b7ceb6faf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Akorn
- Application
- ANDA074076
- Marketing category
- ANDA
- Marketing start
- 1995-07-03
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50383-779-08 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-16 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-17 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-31 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-32 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-33 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-08 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-16 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-17 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-31 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-32 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
| 50383-779-33 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1a3e-111a-e063-dadaa90a10e2 | LACTULOSE SOLUTION, USP |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-779 | LACTULOSE SOLUTION [AKORN] | 9 | Legacy NDC | 20230120_19455240-16b6-4e25-a5c9-a6c965e5ec19.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 |
|---|
| 50383-779-08 | 50383077908 | 237 mL in 1 BOTTLE (50383-779-08) | 237 ml | 1995-07-03 | 0000-00-00 | No | No | Current |
| 50383-779-16 | 50383077916 | 473 mL in 1 BOTTLE (50383-779-16) | 473 ml | 1995-07-03 | 0000-00-00 | No | No | Current |
| 50383-779-17 | 50383077917 | 4 TRAY in 1 CASE (50383-779-17) > 10 CUP in 1 TRAY (50383-779-15) > 15 mL in 1 CUP | 4 tray | 2009-09-04 | 0000-00-00 | No | No | Current |
| 50383-779-31 | 50383077931 | 4 TRAY in 1 CASE (50383-779-31) > 10 CUP in 1 TRAY (50383-779-30) > 30 mL in 1 CUP | 4 tray | 2009-09-04 | 0000-00-00 | No | No | Current |
| 50383-779-32 | 50383077932 | 946 mL in 1 BOTTLE (50383-779-32) | 946 ml | 1995-07-03 | 0000-00-00 | No | No | Current |
| 50383-779-33 | 50383077933 | 10 TRAY in 1 CASE (50383-779-33) > 10 CUP in 1 TRAY > 30 mL in 1 CUP | 10 tray | 2009-09-04 | 0000-00-00 | No | No | Current |