Over-the-counter drug · ANDA
Guaifenesin NDC 76162-031
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · TOPCO ASSOCIATES LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-031-56 | 76162003156 | 4 BLISTER PACK in 1 CARTON (76162-031-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 22, 2026 |
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)
- Guaifenesin
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- TOPCO ASSOCIATES LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210453
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 76162-031_df5d7fac-fdbc-4ebd-bcb9-0e67a891101fSPL ID df5d7fac-fdbc-4ebd-bcb9-0e67a891101fSPL set ID 3a6e96d3-ac86-f388-e063-6394a90ade2dRxCUI 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
N476162003156followed by a unit qualifier and the quantityPackage 76162-0031-56. 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.
Other NDCs under ANDA 210453
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 | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | VESPYR BRANDS LLC | 71179-002 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-853 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-857 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-864 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-865 |
| Mucus Relief Maxguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Better Living Brands, LLC | 21130-399 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-960 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-0028 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | RITE AID CORPORATION | 11822-4260 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-0033 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-561 |
| 365 Whole Foods Market Guaifenesinguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Whole Foods Market, Inc. | 42681-0057 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Better Living Brands LLC | 21130-179 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-811 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-810 |