Search by Drug Name or NDC
NDC 00121-4577-50 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 PAI Holdings, LLC. The primary component is LACTULOSE.
Product Information
| NDC | 00121-4577 |
|---|---|
| Product ID | 0121-4577_fb1e9286-2489-4141-87b8-1039e49f0d83 |
| Associated GPIs | 46600020002010 |
| GCN Sequence Number | 068243 |
| GCN Sequence Number Description | lactulose SOLUTION 10 G/15 ML ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 30994 |
| 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 | PAI Holdings, LLC |
| 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 | ANDA074623 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-4577-50 (00121457750)
| NDC Package Code | 0121-4577-50 |
|---|---|
| Billing NDC | 00121457750 |
| Package | 5 TRAY in 1 CASE (0121-4577-50) / 5 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4577-15) |
| Marketing Start Date | 2022-11-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |