Lactulose
- Product NDC
- 0603-1378
- 11-digit product format
- 006031378
- Labeler code
- 0603
- Product ID
- 0603-1378_018c26f5-288d-4149-83cd-e3d8bb45d8c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lactulose
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA075993
- Marketing category
- ANDA
- Marketing start
- 2001-07-26
- Marketing end
- 2019-10-31
- 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
- 0000-00-00
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-1378-56 | ML - Milliliter | 0603-1378 | 8c157d30-de9c-44b0-97d1-55f001d2e22b | 1 | 2012-07-24 |
| 0603-1378-58 | ML - Milliliter | 0603-1378 | 9e530e09-ed02-4977-b8dd-af50a7451673 | 1 | 2012-07-24 |
| 0603-1378-59 | ML - Milliliter | 0603-1378 | d26f79b4-aec9-4055-98be-0dffc2f264e5 | 1 | 2012-07-24 |
| 0603-1378-65 | ML - Milliliter | 0603-1378 | b404d419-ccc5-42cc-9b8e-0b78ce6b6d0a | 1 | 2012-07-24 |
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 RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 391937 | lactulose 10 GM in 15 mL Oral Solution | PSN | 9081e562-ce03-4781-a62d-e5a27320e096 | 7 |
| 391937 | lactulose 667 MG/ML Oral Solution | SCD | 9081e562-ce03-4781-a62d-e5a27320e096 | 7 |
| 391937 | lactulose 10 GM per 15 ML Oral Solution | SY | 9081e562-ce03-4781-a62d-e5a27320e096 | 7 |
| 391937 | lactulose 20 GM per 30 ML Oral Solution | SY | 9081e562-ce03-4781-a62d-e5a27320e096 | 7 |
| 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 |