Over-the-counter drug · ANDA
Guaifenesin and Dextromethorphan HBr NDC 41415-999
Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 · Tablet, Extended release · Oral · PUBLIX SUPER MARKETS, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41415-999-14 | 41415099914 | 1 BLISTER PACK in 1 CARTON (41415-999-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Guaifenesin and Dextromethorphan HBr
- Generic name (nonproprietary)
- guaifenesin and dextromethorphan hbr
- Active ingredients
- Guaifenesin — 1200 mg/1Dextromethorphan hydrobromide — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- PUBLIX SUPER MARKETS, INC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214781
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 41415-999_1f339b80-92ff-41e0-a8e9-99e44c9609d7SPL ID 1f339b80-92ff-41e0-a8e9-99e44c9609d7SPL set ID 9870b7ee-2bfb-42f5-9762-77d2dd13434aRxCUI 1099074UNII 495W7451VQ, 9D2RTI9KYH
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N441415099914followed by a unit qualifier and the quantityPackage 41415-0999-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 214781
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | PUBLIX SUPER MARKETS, INC | 41415-998 |
| Mucus Relief - DM Maximum Strengthguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | YYBA CORP | 73581-405 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | OHM LABORATORIES INC | 51660-110 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | OHM LABORATORIES INC | 51660-301 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 63304-106 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 63304-110 |
| Guaifenesin And Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-948 |
| Guaifenesin And Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-963 |
| Guaifenesin and Dextromethorphan Hydrobromide HBRguaifenesin and dextromethorphan hydrobromide | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | RITE-AID | 11822-9996 |
| Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS PHARMACY, INC | 51316-600 |