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NDC 00116-4005-11 Lactulose 10 g/15mL Details
Lactulose 10 g/15mL
Lactulose is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is LACTULOSE.
MedlinePlus Drug Summary
Lactulose is a synthetic sugar used to treat constipation. It is broken down in the colon into products that pull water out from the body and into the colon. This water softens stools. Lactulose is also used to reduce the amount of ammonia in the blood of patients with liver disease. It works by drawing ammonia from the blood into the colon where it is removed from the body. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 00116-4005-11Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lactulose
Product Information
| NDC | 00116-4005 |
|---|---|
| Product ID | 0116-4005_f76adfa2-7250-3365-e053-6294a90a1bff |
| Associated GPIs | |
| GCN Sequence Number | 029054 |
| GCN Sequence Number Description | lactulose SOLUTION 10 G/15 ML ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 10167 |
| HICL Sequence Number | 001396 |
| HICL Sequence Number Description | LACTULOSE |
| Brand/Generic | Generic |
| Proprietary Name | Lactulose |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lactulose |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | g/15mL |
| Substance Name | LACTULOSE |
| Labeler Name | Xttrium Laboratories, Inc. |
| Pharmaceutical Class | Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075911 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00116-4005-11 (00116400511)
| NDC Package Code | 0116-4005-11 |
|---|---|
| Billing NDC | 00116400511 |
| Package | 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) |
| Marketing Start Date | 2022-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |