Over-the-counter drug · ANDA
Maximum Strength Mucus Relief DM NDC 0363-0510
guaifenesin and dextromethorphan hbr · Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 · Tablet, Extended release · Oral · WALGREEN CO.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0510-65 | 00363051065 | 2 BLISTER PACK in 1 CARTON (0363-0510-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 17, 2017 | |
| 0363-0510-70 | 00363051070 | 4 BLISTER PACK in 1 CARTON (0363-0510-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 17, 2017 | |
| 0363-0510-99 | 00363051099 | 6 BLISTER PACK in 1 CARTON (0363-0510-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 17, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Maximum Strength Mucus Relief DM
- 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
- WALGREEN CO.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206941
- 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 0363-0510_12933549-899f-44ac-be98-afc7feb3e95eSPL ID 12933549-899f-44ac-be98-afc7feb3e95eSPL set ID 83483b91-77e5-42ca-a467-21312ef32d30RxCUI 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
N400363051065followed by a unit qualifier and the quantityPackage 00363-0510-65. 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 206941
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 | TOPCO ASSOCIATES LLC | 76162-032 |
| Mucus Relief DMguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Ahold U.S.A., Inc, | 60000-057 |
| Mucus Relief DMguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Ahold U.S.A., Inc, | 60000-058 |
| Mucus Relief DMguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Harris Teeter | 72036-012 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-046 |
| Mucus Relief DM Expectorant and Cough Suppressantguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Winco Foods, LLC. | 67091-314 |
| Mucus Relief DM Expectorant and Cough Suppressant Maximum Strengthguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Winco Foods, LLC. | 67091-315 |
| Amazon Basic Care Mucus DMguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-220 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-714 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-715 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-276 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-275 |
| Mucus DMguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-420 |
| Mucus Relief DMguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Harris Teeter | 72036-980 |
| Mucus DM Extended Releaseguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-057 |
| Maximum Strength Mucus DM Extended Releaseguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-059 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-824 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-150 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-825 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Target Corporation | 11673-267 |
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