Over-the-counter drug · ANDA
Guaifenesin Extended Release (guaifenesin) NDC 68196-996
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · SAM'S WEST INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-996-56 | 68196099656 | 4 BLISTER PACK in 1 CARTON (68196-996-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 12, 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 Extended ReleaseSuffix: Extended Release
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- SAM'S WEST 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 68196-996_1cb900ed-18b4-4999-a149-0b4667abcda1SPL ID 1cb900ed-18b4-4999-a149-0b4667abcda1SPL set ID 64297bb8-cd4e-46d3-ae79-ea4aa4c03bcaRxCUI 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
N468196099656followed by a unit qualifier and the quantityPackage 68196-0996-56. 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 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 | AMERISOURCE BERGEN | 46122-750 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories, Inc. | 51660-566 |
| 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 |