Over-the-counter drug · ANDA
Mucus Relief Extended Release (guaifenesin) NDC 0536-1163
Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Rugby Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1163-61 | 00536116361 | 100 BLISTER PACK in 1 CARTON (0536-1163-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 31, 2018 |
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 Extended Release
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Rugby Laboratories, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207342
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 0536-1163_ed6550fd-e566-47aa-9de7-f3245592b45cSPL ID ed6550fd-e566-47aa-9de7-f3245592b45cSPL set ID 8bc6f08e-a941-4fa8-8dd6-a699abf2337dRxCUI 636522UNII 495W7451VQUPC 0305361163617
- 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
N400536116361followed by a unit qualifier and the quantityPackage 00536-1163-61. 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 makes coughs more productive.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207342
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 600 mg/1 | TabletOral | Rite Aid Corporation | 11822-3252 |
| Mucus Relief Extended Release Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0479 |
| Mucus Relief ERguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-6718 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | H E B | 37808-935 |
| Mucus Relief Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | TARGET Corporation | 11673-732 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1052 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1051 |
| Mucus Relief ERguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Cardinal Health 107, LLC | 55154-4153 |
| Mucus Relief Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Care One (American Sales Company) | 41520-732 |
| Mucus Relief Extended Releaseguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Care One (American Sales Company) | 41520-731 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Harris Teeter, LLC | 69256-731 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | WinCo Foods, LLC | 67091-370 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-036 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-037 |
| Mucus Relief Extended Release Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Walgreens | 0363-0832 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-739 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | P & L Development, LLC | 59726-237 |
| Mucus Relief Extended Releaseguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Redpharm Drug Inc. | 67296-1467 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-731 |
| Mucus Relief Extended Release Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | H E B | 37808-762 |
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