NDC product
Diphenoxylate Hydrochloride and Atropine Sulfate
NDC 0054-3194 · Hikma Pharmaceuticals USA Inc.
Key facts
| Product NDC | 0054-3194 |
|---|---|
| Proprietary name | Diphenoxylate Hydrochloride and Atropine Sulfate |
| Nonproprietary name | Diphenoxylate Hydrochloride and Atropine Sulfate |
| Substances | DIPHENOXYLATE HYDROCHLORIDE, ATROPINE SULFATE |
| Dosage form | SOLUTION |
| Route | ORAL |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA087708 |
| DEA schedule | CV |
| Pharmacologic classes | Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
| Marketing start | May 3, 1982 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: