Over-the-counter drug · ANDA
Guaifenesin NDC 51660-566
Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Ohm Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51660-566-21 | 51660056621 | 20 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-21)Marketed from Apr 1, 2022 | |
| 51660-566-41 | 51660056641 | 40 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-41)Marketed from Apr 1, 2022 | |
| 51660-566-68 | 51660056668 | 68 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-68)Marketed from Jan 17, 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 — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Ohm Laboratories, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209254
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 51660-566_4aa4fb35-6f33-6e33-e063-6394a90a495eSPL ID 4aa4fb35-6f33-6e33-e063-6394a90a495eSPL set ID 7076e42a-17ff-4c42-9963-2dc02c0a5e49RxCUI 310621, 636522UNII 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
N451660056621followed by a unit qualifier and the quantityPackage 51660-0566-21. 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 bronchial mucus and make coughs more productive
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209254
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 Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-996 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | AMERISOURCE BERGEN | 46122-750 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories, Inc. | 51660-567 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-961 |
| Guaifenesin Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-962 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Walmart Stores, Inc. | 79903-124 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CVS | 51316-071 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Publix Super Markets, Inc | 41415-996 |
| Guaifenesin Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | PUBLIX SUPER MARKETS, INC | 41415-997 |