Over-the-counter drug · ANDA
Guaifenesin NDC 51660-567
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Ohm Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51660-567-54 | 5166005675451660056754 | 14 TABLET, EXTENDED RELEASE in 1 CARTON (51660-567-54)Marketed from Apr 1, 2022 | |
| 51660-567-58 | 5166005675851660056758 | 56 TABLET, EXTENDED RELEASE in 1 CARTON (51660-567-58)Marketed from Apr 1, 2022 | |
| 51660-567-86 | 5166005678651660056786 | 28 TABLET, EXTENDED RELEASE in 1 CARTON (51660-567-86)Marketed from Apr 1, 2022 |
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
- Ohm Laboratories, Inc.NDC labeler code 51660
- 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 51660-567_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
N451660056754followed by a unit qualifier and the quantityPackage 51660-0567-54. 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.
About NDC 51660-567
- What is NDC 51660-567?
- 51660-567 is the product NDC for Guaifenesin, Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Ohm Laboratories, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin.
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Ohm Laboratories, Inc., NDC labeler code 51660. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Guaifenesin?
- 63 other product NDCs are listed under this name. See all Guaifenesin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | INNOVUS PHARMACEUTICALS, INC. | 57483-144 | 57483-0144-28 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-857 | 58602-0857-93 |
| Guaifenesinguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Zennova LLC | 81993-002 | 81993-0002-0181993-0002-0281993-0002-03+2 more |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-031 | 76162-0031-56 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | YYBA CORP | 73581-400 | 73581-0400-0273581-0400-07 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-960 | 68196-0960-56 |
| Guaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | KESIN PHARMA CORPORATION | 81033-102 | 81033-0102-16 |
| Guaifenesin | Guaifenesin 100 mg/5mL | SolutionOral | American Health Packaging | 60687-852 | 60687-0852-17 |
| Guaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | American Health Packaging | 60687-863 | 60687-0863-56 |
| Guaifenesin | Guaifenesin 300 mg/15mL | SolutionOral | American Health Packaging | 60687-874 | 60687-0874-16 |
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 | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-961 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Publix Super Markets, Inc | 41415-996 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | AMERISOURCE BERGEN | 46122-750 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CVS | 51316-071 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories, Inc. | 51660-566 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Walmart Stores, Inc. | 79903-124 |
| Guaifenesin Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-962 |
| Guaifenesin Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | PUBLIX SUPER MARKETS, INC | 41415-997 |
| Guaifenesin Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-996 |