Lactulose
- Product NDC
- 62135-003
- 11-digit product format
- 621350003
- Labeler code
- 62135
- Product ID
- 62135-003_456e6761-40f8-db90-e063-6394a90a2393
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC.
- Application
- ANDA209517
- Marketing category
- ANDA
- Marketing start
- 2018-11-23
- 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 |
|---|
| 62135-003-37 | Lactulose | 237 mL in 1 BOTTLE, PLASTIC | SOLUTION | 237 | | 4 |
| 62135-003-47 | Lactulose | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | | 4 |
| 62135-003-78 | Lactulose | 3785 mL in 1 BOTTLE, PLASTIC | SOLUTION | 3785 | | 4 |
| 62135-003-94 | Lactulose | 946 mL in 1 BOTTLE, PLASTIC | SOLUTION | 946 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-003 | LACTULOSE SOLUTION [CHARTWELL RX, LLC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241030_bd9f1577-65e8-4521-b176-e5fc60a4a018.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 |
|---|
| 62135-003-37 | 62135000337 | 237 mL in 1 BOTTLE, PLASTIC (62135-003-37) | 237 ml | 2021-01-10 | 0000-00-00 | No | No | Current |
| 62135-003-47 | 62135000347 | 473 mL in 1 BOTTLE, PLASTIC (62135-003-47) | 473 ml | 2021-01-10 | 0000-00-00 | No | No | Current |
| 62135-003-78 | 62135000378 | 3785 mL in 1 BOTTLE, PLASTIC (62135-003-78) | 3785 ml | 2021-01-10 | 0000-00-00 | No | No | Current |
| 62135-003-94 | 62135000394 | 946 mL in 1 BOTTLE, PLASTIC (62135-003-94) | 946 ml | 2021-01-10 | 0000-00-00 | No | No | Current |