Over-the-counter drug · ANDA
Members Mark Mucus Relief DM (Guaifenesin and dextromethorphan hbr) NDC 68196-999
Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 · Tablet, Extended release · Oral · SAM'S WEST INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-999-56 | 6819609995668196099956 | 4 BLISTER PACK in 1 CARTON (68196-999-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 30, 2024 |
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)
- Members Mark 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
- SAM'S WEST INCNDC labeler code 68196
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217340
- 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 68196-999_353ffab0-e812-3948-08ea-c649e60aa08fSPL ID 353ffab0-e812-3948-08ea-c649e60aa08fSPL set ID 2b59f90b-b8fc-03c0-3527-a8efa97fbfe3RxCUI 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
N468196099956followed by a unit qualifier and the quantityPackage 68196-0999-56. 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 68196-999
- What is NDC 68196-999?
- 68196-999 is the product NDC for Members Mark Mucus Relief DM, Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 tablet, extended release, listed with the FDA by SAM'S WEST INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Members Mark Mucus Relief DM (Guaifenesin and Dextromethorphan HBR).
- What is the active ingredient?
- Guaifenesin, Dextromethorphan hydrobromide.
- Who is the labeler?
- SAM'S WEST INC, NDC labeler code 68196. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Members Mark Mucus Relief DM?
- 1 other product NDC are listed under this name. See all Members Mark Mucus Relief DM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Members Mark Mucus Relief 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) |
|---|---|---|---|---|---|
| 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 | 68196-0812-45 |
Other NDCs under ANDA 217340
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 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-114 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-231 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-232 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-009 |