LACTULOSE
- Product NDC
- 82804-107
- 11-digit product format
- 828040107
- Labeler code
- 82804
- Product ID
- 82804-107_6bbabdc6-f6a8-4f67-a448-e452d1928deb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA074623
- Marketing category
- ANDA
- Marketing start
- 2019-12-03
- 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 |
|---|
| 82804-107-47 | LACTULOSE | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-107 | LACTULOSE SOLUTION [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20240622_6bbabdc6-f6a8-4f67-a448-e452d1928deb.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 |
|---|
| 82804-107-47 | 82804010747 | 473 mL in 1 BOTTLE (82804-107-47) | 473 ml | 2024-06-14 | No | No | Current |