Over-the-counter drug · ANDA
Mucus Relief ER (guaifenesin) NDC 0536-1249
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1249-71 | 00536124971 | 2 BLISTER PACK in 1 CARTON (0536-1249-71) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 21, 2025 |
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)
- Mucus Relief ER
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Rugby Laboratories
- 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 0536-1249_3b5fbc86-cb0e-468d-e063-6394a90a811fSPL ID 3b5fbc86-cb0e-468d-e063-6394a90a811fSPL set ID 2e6901aa-16f6-9b73-e063-6294a90a4d72RxCUI 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
N400536124971followed by a unit qualifier and the quantityPackage 00536-1249-71. 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.
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 | CVS Pharmacy | 51316-724 |
| 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 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-033 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0730 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Grocery Outlet, Inc. | 85828-723 |
| 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 | KROGER COMPANY | 41226-723 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-724 |