Lactulose
- Product NDC
- 0116-4005
- 11-digit product format
- 001164005
- Labeler code
- 0116
- Product ID
- 0116-4005_4f6f0368-4b59-a9df-e063-6294a90ae43c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lactulose
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Xttrium Laboratories, Inc.
- Application
- ANDA075911
- Marketing category
- ANDA
- Marketing start
- 2022-07-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lactulose
- Listing expiration
- 2027-12-31
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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0116-4005 | LACTULOSE SOLUTION [XTTRIUM LABORATORIES, INC.] | 6 | Current NDC, Legacy NDC, 11 package rows | 20250514_df62ad54-5aba-4d05-e053-2a95a90aa48d.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 |
|---|
| 0116-4005-08 | 00116400508 | 237 mL in 1 BOTTLE (0116-4005-08) | 237 ml | 2022-07-01 | 0000-00-00 | No | No | Current |
| 0116-4005-10 | 00116400510 | 100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) | 100 case | 2022-07-01 | 0000-00-00 | No | No | Current |
| 0116-4005-11 | 00116400511 | 100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) | 100 case | 2022-07-01 | 0000-00-00 | No | No | Current |
| 0116-4005-15 | 00116400515 | 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) | 15 ml | 2022-07-01 | 0000-00-00 | No | No | Current |
| 0116-4005-16 | 00116400516 | 473 mL in 1 BOTTLE (0116-4005-16) | 473 ml | 2022-07-01 | 0000-00-00 | No | No | Current |
| 0116-4005-30 | 00116400530 | 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) | 30 ml | 2022-07-01 | 0000-00-00 | No | No | Current |
| 0116-4005-32 | 00116400532 | 946 mL in 1 BOTTLE (0116-4005-32) | 946 ml | 2022-07-01 | 0000-00-00 | No | No | Current |
| 0116-4005-40 | 00116400540 | 10 in 1 TRAY | | | | | | Historical |
| 0116-4005-41 | 00116400541 | 40 in 1 CASE | | | | | | Historical |