Over-the-counter drug · ANDA
Guaifenesin Extended Release (guaifenesin) NDC 41415-997
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · PUBLIX SUPER MARKETS, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41415-997-14 | 41415099714 | 1 BLISTER PACK in 1 CARTON (41415-997-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 10, 2017 |
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
- PUBLIX SUPER MARKETS, 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 41415-997_358eee0d-f68a-daf8-e063-6394a90a4d07SPL ID 358eee0d-f68a-daf8-e063-6394a90a4d07SPL set ID 038e1801-b978-4a2e-ae8c-8803596ec09cRxCUI 310621UNII 495W7451VQUPC 0041415527737
- 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
N441415099714followed by a unit qualifier and the quantityPackage 41415-0997-14. 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 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 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 |