Lactulose
- Product NDC
- 17856-1378
- 11-digit product format
- 178561378
- Labeler code
- 17856
- Product ID
- 17856-1378_fa34b11e-85d6-4c9e-bc71-3db28dd39ec3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lactulose
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- Application
- ANDA075993
- Marketing category
- ANDA
- Marketing start
- 2001-07-26
- Marketing end
- 0000-00-00
- Substance
- LACTULOSE
- Active strength
- 10 g/15mL
- Pharmacologic classes
- Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 13620a32-e3b4-4aad-8280-283dce30ddff | Product name | 1 | 20260105 |
| 27883b46-af31-44b0-b4ce-e6b4f6d825a7 | Product name | 4 | 20250812 |
| c1a80c95-0e51-52a0-75fa-75808f51ded8 | Product name | 2 | 20150421 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-1378-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2247-0266-e053-dadaa90a7c1a | LACTULOSE SOLUTION, USP Rx only |
| 17856-1378-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2247-0266-e053-dadaa90a7c1a | LACTULOSE SOLUTION, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-1378-1 | Lactulose | 30 mL in 1 CUP | SOLUTION | 30 | 6 | |
| 17856-1378-2 | Lactulose | 15 mL in 1 CUP | SOLUTION | 15 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-1378-1 | ML - Milliliter | 17856-1378 | 64f4ad95-fa33-4fda-a3a2-0bc5304f7f1a | 1 | 2013-06-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LACTULOSE | ACTIVE INGREDIENT | 9U7D5QH5AE | LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| LACTULOSE | ACTIVE MOIETY | 9U7D5QH5AE | LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-1378 | LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | Legacy NDC, 2 package rows | 20210129_287b0b8b-962b-4f05-b770-5dc9d170d1d0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 391937 | lactulose 10 GM in 15 mL Oral Solution | PSN | 287b0b8b-962b-4f05-b770-5dc9d170d1d0 | 6 |
| 391937 | lactulose 667 MG/ML Oral Solution | SCD | 287b0b8b-962b-4f05-b770-5dc9d170d1d0 | 6 |
| 391937 | lactulose 10 GM per 15 ML Oral Solution | SY | 287b0b8b-962b-4f05-b770-5dc9d170d1d0 | 6 |
| 391937 | lactulose 20 GM per 30 ML Oral Solution | SY | 287b0b8b-962b-4f05-b770-5dc9d170d1d0 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 17856-1378-1 | 17856137801 | 30 mL in 1 CUP (17856-1378-1) | 30 ml | 2021-01-28 | 0000-00-00 | No | No | Current |
| 17856-1378-2 | 17856137802 | 15 mL in 1 CUP (17856-1378-2) | 15 ml | 2021-01-28 | 0000-00-00 | No | No | Current |