Over-the-counter drug · ANDA
Topcare Mucus DM (Dextromethorphan hbr, guaifenesin) NDC 36800-592
Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 · Tablet, Extended release · Oral · Topco Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-592Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0592Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-592-30 | 3680005923036800059230 | 1 BOTTLE in 1 CARTON (36800-592-30) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 29, 2022 | |
| 36800-592-66 | 3680005926636800059266 | 1 BOTTLE in 1 CARTON (36800-592-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Sep 6, 2018 |
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 hbr, guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1Dextromethorphan hydrobromide — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- 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 36800-592_9a7d9f3f-d507-4b50-a253-80b72f8a5a95SPL ID 9a7d9f3f-d507-4b50-a253-80b72f8a5a95
- 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
N436800059230followed by a unit qualifier and the quantityPackage 36800-0592-30. 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.
About NDC 36800-592
- What is NDC 36800-592?
- 36800-592 is the product NDC for Topcare Mucus DM, Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 tablet, extended release, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topcare Mucus DM (Dextromethorphan HBr, guaifenesin).
- What is the active ingredient?
- Guaifenesin, Dextromethorphan hydrobromide.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topcare Mucus DM?
- 1 other product NDC are listed under this name. See all Topcare Mucus DM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Topcare Mucus DM products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topcare Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Topco Associates LLC | 36800-219 | 36800-0219-0136800-0219-49 |
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 |
|---|---|---|---|---|
| basic care mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-812 |
| mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Meijer Distribution Inc | 41250-812 |
| mucus dmdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | HyVee Inc | 42507-812 |
| 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 |
| Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | L. Perrigo Company | 0113-2219 |
| Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-172 |
| 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 Relief DMdextromethorphan hydrobromide, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-671 |
| up and up mucus relief dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Target Corporation | 11673-716 |
| Good Neighbor Pharmacy Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-817 |
| Berkley and Jensen Mucus Relief DMdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | BJWC | 68391-812 |
| mucus dm extended releaseguaifenesin, dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 69842-812 |
| members mark mucus relief dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-812 |
| mucus relief dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Meijer Distribution Inc | 41250-436 |
| kirkland signature mucus dmdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Costco Wholesale Company | 63981-812 |
| Topcare Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Topco Associates LLC | 36800-219 |
| equaline mucus dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | United Natural Foods, Inc. dba UNFI | 41163-599 |
| Mucus DM Maxdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-420 |
| Rugby Mucus Relief DM ERdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1446 |
| Mucus Relief DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Walgreen Company | 0363-3219 |
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