NDC product
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief
NDC 0031-8765 · Haleon US Holdings LLC
Key facts
| Product NDC | 0031-8765 |
|---|---|
| Proprietary name | Robitussin Maximum Strength 12 Hour Cough and Mucus Relief |
| Nonproprietary name | Dextromethorphan Hydrobromide, Guaifenesin |
| Substances | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Labeler | Haleon US Holdings LLC |
| Product type | HUMAN OTC DRUG |
| Marketing category | ANDA |
| Application number | ANDA207602 |
| Pharmacologic classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] and 1 more |
| Marketing start | Jun 14, 2019 |
| 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: