Over-the-counter drug · ANDA
Leader Mucus Relief DM NDC 70000-0722
dextromethorphan hydrobromide, guaifenesin · Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0722-1 | 7000007220170000072201 | 1 BOTTLE in 1 CARTON (70000-0722-1) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Mar 8, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Leader Mucus Relief 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
- Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
- 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 70000-0722_00d1560d-9781-4c69-b051-dc92235f0db1SPL ID 00d1560d-9781-4c69-b051-dc92235f0db1SPL set ID 7c54d128-9da7-49d7-bda4-9d4f7b8bc652RxCUI 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
N470000072201followed by a unit qualifier and the quantityPackage 70000-0722-01. 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.
About NDC 70000-0722
- What is NDC 70000-0722?
- 70000-0722 is the product NDC for Leader Mucus Relief DM, Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 tablet, extended release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leader Mucus Relief DM (Dextromethorphan hydrobromide, guaifenesin).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin.
- Who is the labeler?
- Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leader Mucus Relief DM?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| Berkley and Jensen Mucus Relief DMdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | BJWC | 68391-812 |
| DG health mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dolgencorp, LLC | 55910-575 |
| DG health mucus dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Dolgencorp Inc | 55910-746 |
| 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 |
| Equaline Mucus DMdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | United Natural Foods, Inc. dba UNFI | 41163-781 |
| equate mucus relief dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | WALMART INC. | 79903-065 |
| 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 |
| good neighbor pharmacy mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-637 |
| Good Neighbor Pharmacy Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-817 |
| good sense mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | L Perrigo Company | 0113-0812 |
| 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 hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7258 |
| Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-172 |
| kirkland signature mucus dmdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Costco Wholesale Company | 63981-812 |
| 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 dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Meijer Distribution Inc | 41250-812 |
| Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | HyVee Inc | 42507-222 |
| mucus dmdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | HyVee Inc | 42507-812 |
| mucus dm extended releaseguaifenesin, dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 69842-812 |
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