Over-the-counter drug · ANDA
Leader Cough DM (Dextromethorphan polistirex) NDC 70000-0302
Dextromethorphan hydrobromide 30 mg/5mL · Suspension, Extended release · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0302-1 | 70000030201 | 1 BOTTLE in 1 CARTON (70000-0302-1) / 89 mL in 1 BOTTLEMarketed from Jun 6, 2017 | |
| 70000-0302-2 | 70000030202 | 1 BOTTLE in 1 CARTON (70000-0302-2) / 148 mL in 1 BOTTLEMarketed from Apr 8, 2026 |
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 Cough DMSuffix: DM
- Generic name (nonproprietary)
- dextromethorphan polistirex
- Active ingredients
- Dextromethorphan hydrobromide — 30 mg/5mL
- Dosage form
- Suspension, 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 091135
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70000-0302_c2af792f-30a1-4f16-8b10-1822d23df4eeSPL ID c2af792f-30a1-4f16-8b10-1822d23df4eeSPL set ID a07b70d0-3842-4ea6-abb4-95b4638d5e55RxCUI 1373045UNII 9D2RTI9KYH
- Pharmacologic class
- 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
N470000030201followed by a unit qualifier and the quantityPackage 70000-0302-01. 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 temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
About NDC 70000-0302
- What is NDC 70000-0302?
- 70000-0302 is the product NDC for Leader Cough DM (dextromethorphan polistirex), Dextromethorphan hydrobromide 30 mg/5mL suspension, extended release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leader Cough DM (Dextromethorphan polistirex).
- What is the active ingredient?
- Dextromethorphan hydrobromide.
- 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 Cough DM?
- 1 other product NDC are listed under this name. See all Leader Cough DM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Leader Cough 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) |
|---|---|---|---|---|---|
| Leader Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Cardinal Health 110, LLC. dba Leader | 70000-0187 | 70000-0187-01 |
Other NDCs under ANDA 091135
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 |
|---|---|---|---|---|
| 12 Hr Relief Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-263 |
| 12 hr relief cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-943 |
| basic care childrens cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-899 |
| basic care childrens cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-958 |
| basic care cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-384 |
| basic care cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Amazon.com Services LLC | 72288-494 |
| CareOne Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | American Sales Company | 41520-384 |
| CareOne Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | American Sales Company | 41520-958 |
| Childrens 12 Hr Cough Reliefdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-429 |
| childrens cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Walgreen Company | 0363-0899 |
| Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Haleon US Holdings LLC | 0031-8725 |
| Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Haleon US Holdings LLC | 0031-8726 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Walgreen Company | 0363-0384 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Walgreen Company | 0363-0494 |
| cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Major Pharmaceuticals | 0904-6312 |
| cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-6312 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Safeway | 21130-538 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Kroger Company | 30142-384 |
| cough dmdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | Suspension, Extended releaseOral | Kroger Company | 30142-494 |
| Cough DMdextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | H E B | 37808-384 |
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