Lactulose Solution
- Product NDC
- 61037-471
- 11-digit product format
- 610370471
- Labeler code
- 61037
- Product ID
- 61037-471_f0b79991-a87f-2b4b-e053-2995a90a8690
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose Solution USP, 10 g/15 mL
- Dosage form
- SOLUTION
- Route
- ORAL; RECTAL
- Labeler
- Bajaj Medical, LLC
- Application
- ANDA076645
- Marketing category
- ANDA
- Marketing start
- 2021-10-14
- 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 Solution
- 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 |
|---|
| 61037-471-02 | Lactulose Solution | 236 mL in 1 BOTTLE | SOLUTION | 236 | | 2 |
| 61037-471-03 | Lactulose Solution | 946 mL in 1 BOTTLE | SOLUTION | 946 | | 2 |
| 61037-471-04 | Lactulose Solution | 1893 mL in 1 JUG | SOLUTION | 1893 | | 2 |
| 61037-471-05 | Lactulose Solution | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | | 2 |
| 61037-471-06 | Lactulose Solution | 3785 mL in 1 JUG | SOLUTION | 3785 | | 2 |
| 61037-471-12 | Lactulose Solution | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 2 |
| 61037-471-13 | Lactulose Solution | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 2 |
| 61037-471-14 | Lactulose Solution | 30 mL in 1 CUP, UNIT-DOSE | SOLUTION | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61037-471 | LACTULOSE SOLUTION (LACTULOSE SOLUTION USP, 10 G/15 ML) SOLUTION [BAJAJ MEDICAL, LLC] | 2 | Current NDC, Legacy NDC, 8 package rows | 20221227_d460b1a2-9091-2ac9-e053-2995a90aa1d2.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 |
|---|
| 61037-471-02 | 61037047102 | 236 mL in 1 BOTTLE (61037-471-02) | 236 ml | 2021-10-14 | 0000-00-00 | No | No | Current |
| 61037-471-03 | 61037047103 | 946 mL in 1 BOTTLE (61037-471-03) | 946 ml | 2021-10-14 | 0000-00-00 | No | No | Current |
| 61037-471-04 | 61037047104 | 1893 mL in 1 JUG (61037-471-04) | 1893 ml | 2021-10-14 | 0000-00-00 | No | No | Current |
| 61037-471-05 | 61037047105 | 15 mL in 1 CUP, UNIT-DOSE (61037-471-05) | 15 ml | 2021-10-14 | 0000-00-00 | No | No | Current |
| 61037-471-06 | 61037047106 | 3785 mL in 1 JUG (61037-471-06) | 3785 ml | 2021-10-14 | 0000-00-00 | No | No | Current |
| 61037-471-12 | 61037047112 | 473 mL in 1 BOTTLE (61037-471-12) | 473 ml | 2021-10-14 | 0000-00-00 | No | No | Current |
| 61037-471-13 | 61037047113 | 118 mL in 1 BOTTLE (61037-471-13) | 118 ml | 2021-10-14 | 0000-00-00 | No | No | Current |
| 61037-471-14 | 61037047114 | 30 mL in 1 CUP, UNIT-DOSE (61037-471-14) | 30 ml | 2021-10-14 | 0000-00-00 | No | No | Current |