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NDC 00054-3194-46 Diphenoxylate Hydrochloride and Atropine Sulfate .025; 2.5 mg/5mL; mg/5mL Details
Diphenoxylate Hydrochloride and Atropine Sulfate .025; 2.5 mg/5mL; mg/5mL
Diphenoxylate Hydrochloride and Atropine Sulfate is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE.
MedlinePlus Drug Summary
Diphenoxylate is used along with other treatments such as fluid and electrolyte replacement for the treatment of diarrhea. Diphenoxylate should not be given to children younger than 2 years of age. Diphenoxylate is in a class of medications called antidiarrheal agents. It works by decreasing activity of the bowel.
Related Packages: 00054-3194-46Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenoxylate
Product Information
| NDC | 00054-3194 |
|---|---|
| Product ID | 0054-3194_ac0c72b1-8f3e-4f00-9388-a33945fb1971 |
| Associated GPIs | 47100010100910 |
| GCN Sequence Number | 002839 |
| GCN Sequence Number Description | diphenoxylate HCl/atropine LIQUID 2.5-.025/5 ORAL |
| HIC3 | D6D |
| HIC3 Description | ANTIDIARRHEALS |
| GCN | 65020 |
| HICL Sequence Number | 001235 |
| HICL Sequence Number Description | DIPHENOXYLATE HCL/ATROPINE SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Diphenoxylate Hydrochloride and Atropine Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenoxylate Hydrochloride and Atropine Sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | .025; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
| DEA Schedule | CV |
| Marketing Category | ANDA |
| Application Number | ANDA087708 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-3194-46 (00054319446)
| NDC Package Code | 0054-3194-46 |
|---|---|
| Billing NDC | 00054319446 |
| Package | 1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE |
| Marketing Start Date | 1982-05-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |