Over-the-counter drug · ANDA
Guaifenesin and Dextromethorphan HBR NDC 43598-231
Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 · Tablet, Extended release · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-231-01 | 43598023101 | 5 BLISTER PACK in 1 CARTON (43598-231-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 23, 2023 |
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 — 600 mg/1Dextromethorphan hydrobromide — 30 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217340
- 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 43598-231_e2cca72b-3d64-2919-9631-c911b77a3b0fSPL ID e2cca72b-3d64-2919-9631-c911b77a3b0fSPL set ID 5e95d8c0-d521-45b6-ccaf-7786fbd14d5cRxCUI 1099074, 1298324UNII 9D2RTI9KYH, 495W7451VQ
- 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
N443598023101followed by a unit qualifier and the quantityPackage 43598-0231-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217340
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 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-232 |
| Members Mark Mucus Relief DMguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-999 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-009 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-114 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-115 |