Over-the-counter drug · ANDA
Maximum Strength Mucus Relief (Guaifenesin) NDC 68196-033
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · SAM'S WEST INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-033-56 | 6819600335668196003356 | 4 BLISTER PACK in 1 CARTON (68196-033-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 20, 2025 |
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)
- Maximum Strength Mucus Relief
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 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 217780
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 68196-033_3c3db64c-3dad-c118-e063-6294a90adc1bSPL ID 3c3db64c-3dad-c118-e063-6294a90adc1bSPL set ID 39282544-e1e8-8270-e063-6394a90a23feRxCUI 310621UNII 495W7451VQ
- Pharmacologic class
- Expectorant
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
N468196003356followed by a unit qualifier and the quantityPackage 68196-0033-56. 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
Excerpt only. Read the full label for complete information.
About NDC 68196-033
- What is NDC 68196-033?
- 68196-033 is the product NDC for Maximum Strength Mucus Relief (guaifenesin), Guaifenesin 1200 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?
- Maximum Strength Mucus Relief (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- 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 Maximum Strength Mucus Relief?
- 6 other product NDCs are listed under this name. See all Maximum Strength Mucus Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Maximum Strength Mucus Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1320 | 70677-1320-01 |
| Maximum Strength Mucus Reliefdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/20mL + 2 more ingredients | LiquidOral | Hyvee Inc | 42507-617 | 42507-0617-58 |
| Maximum Strength Mucus Reliefdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | LiquidOral | Hyvee Inc | 42507-630 | 42507-0630-58 |
| Maximum Strength Mucus Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/20mL + 3 more ingredients | LiquidOral | Chain Drug Marketing Association Inc. | 83324-143 | 83324-0143-06 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-724 | 41226-0724-89 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-148 | 63868-0148-14 |
Other NDCs under ANDA 217780
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 |
|---|---|---|---|---|
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | BJWC (Berkley & Jensen / BJ's) | 68391-724 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Grocery Outlet, Inc. | 85828-723 |
| Mucus Relief ERguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1249 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-724 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-723 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-724 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0730 |
| Guaifenesin Extended Release 600 mgguaifenesin | Guaifenesin 600 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-723 |
| Guaifenesin Extended Release 1200 mgguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-724 |
| Guaifenesin 600 mg | Guaifenesin 600 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-042 |
| Guaifenesin 1200 mg | Guaifenesin 1200 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-041 |