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NDC 50383-0357-31 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 Akorn. The primary component is LACTULOSE.
Product Information
NDC | 50383-0357 |
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Product ID | 50383-357_0196a8e5-bda8-4b6c-9f59-dc5fa2e16e0d |
Associated GPIs | |
GCN Sequence Number | 068217 |
GCN Sequence Number Description | lactulose SOLUTION 20 G/30 ML ORAL |
HIC3 | D6S |
HIC3 Description | LAXATIVES AND CATHARTICS |
GCN | 30962 |
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 | Akorn |
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 | ANDA074076 |
Listing Certified Through | 2024-12-31 |
Package
NDC 50383-0357-31 (50383035731)
NDC Package Code | 50383-357-31 |
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Billing NDC | 50383035731 |
Package | 4 TRAY in 1 CASE (50383-357-31) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (50383-357-30) |
Marketing Start Date | 2022-12-21 |
NDC Exclude Flag | N |
Pricing Information | N/A |