Lactulose
- Product NDC
- 50383-795
- 11-digit product format
- 503830795
- Labeler code
- 50383
- Product ID
- 50383-795_e004117b-667e-4761-a11c-dea9c84785a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose
- Dosage form
- SOLUTION
- Route
- ORAL; RECTAL
- Labeler
- Akorn
- Application
- ANDA074077
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50383-795-16 | Lactulose | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 7 |
| 50383-795-64 | Lactulose | 1893 mL in 1 BOTTLE | SOLUTION | 1893 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-795 | LACTULOSE SOLUTION [AKORN] | 7 | Legacy NDC, 2 package rows | 20220916_ff6b4568-1383-46b6-a1c6-385fc31fb210.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 |
|---|
| 50383-795-16 | 50383079516 | 473 mL in 1 BOTTLE (50383-795-16) | 473 ml | 1995-07-03 | 0000-00-00 | No | No | Current |
| 50383-795-64 | 50383079564 | 1893 mL in 1 BOTTLE (50383-795-64) | 1893 ml | 1995-07-03 | 0000-00-00 | No | No | Current |