Over-the-counter drug · ANDA
Topcare Mucus DM NDC 36800-219
dextromethorphan hydrobromide, guaifenesin · Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Topco Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-219Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0219Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-219-01 | 36800021901 | 1 BOTTLE in 1 CARTON (36800-219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 10, 2019 | |
| 36800-219-49 | 36800021949 | 1 BOTTLE in 1 CARTON (36800-219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Apr 13, 2022 |
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)
- Topcare Mucus DM
- Generic name (nonproprietary)
- dextromethorphan hydrobromide, guaifenesin
- Active ingredients
- Dextromethorphan hydrobromide — 30 mg/1Guaifenesin — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Topco Associates LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207602
- 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 36800-219_a59ff297-ad60-4509-bab4-10ff482cb045SPL ID a59ff297-ad60-4509-bab4-10ff482cb045
- 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
N436800021901followed by a unit qualifier and the quantityPackage 36800-0219-01. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 207602
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 |
|---|---|---|---|---|
| Rugby Mucus Relief DM ERdextromethorphan hydrobromide, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7891 |
| up and up mucus relief dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Target Corporation | 11673-716 |
| Robitussin Maximum Strength 12 Hour Cough and Mucus Reliefdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Haleon US Holdings LLC | 0031-8765 |
| mucus dm extended releaseguaifenesin, dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 69842-812 |
| mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Meijer Distribution Inc | 41250-812 |
| Exchange Select Mucus DMdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Army & Air Force Exchange Service | 55301-812 |
| mucus dmdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | HyVee Inc | 42507-812 |
| Mucus Relief DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-858 |
| Topcare Mucus DMdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Topco Associates LLC | 36800-592 |
| DG health mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dolgencorp, LLC | 55910-575 |
| Good Neighbor Pharmacy Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-817 |
| kirkland signature mucus dmdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Costco Wholesale Company | 63981-812 |
| mucus relief dmdextromethorphan hydrobromide, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Walgreen Company | 0363-6812 |
| basic care mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-812 |
| equate mucus relief dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | WALMART INC. | 79903-065 |
| basic care mucus dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-219 |
| mucus dm extended releaseguaifenesin, dextromethorphan hydrobromide | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 69842-963 |
| Rugby Mucus Relief DM ERdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1446 |
| Rugby Mucus Relief DM ERdextromethorphan hydrobromide, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1447 |
| DG health mucus dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Dolgencorp Inc | 55910-746 |
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