NDC product
HYDROXYZINE HYDROCHLORIDE
NDC 10135-811 · Marlex Pharmaceuticals, Inc.
Key facts
| Product NDC | 10135-811 |
|---|---|
| Proprietary name | HYDROXYZINE HYDROCHLORIDE |
| Nonproprietary name | hydroxyzine hydrochloride |
| Substances | HYDROXYZINE DIHYDROCHLORIDE |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Labeler | Marlex Pharmaceuticals, Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA207121 |
| Pharmacologic classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
| Marketing start | Mar 1, 2025 |
| Listing certified through | Dec 31, 2026 |
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: