Over-the-counter drug · NDA
Mucinex (guaifenesin) NDC 63824-008
Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63824-008-15 | 63824000815 | 5 BLISTER PACK in 1 CARTON (63824-008-15) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 | |
| 63824-008-27 | 63824000827 | 4 BLISTER PACK in 1 CARTON (63824-008-27) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 | |
| 63824-008-32 | 63824000832 | 1 BLISTER PACK in 1 CARTON (63824-008-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 | |
| 63824-008-34 | 63824000834 | 2 BLISTER PACK in 1 CARTON (63824-008-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 | |
| 63824-008-36 | 63824000836 | 1 BLISTER PACK in 1 CARTON (63824-008-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 | |
| 63824-008-50 | 63824000850 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-008-50)Marketed from Jul 3, 2012 | |
| 63824-008-69 | 63824000869 | 3 BLISTER PACK in 1 CARTON (63824-008-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 | |
| 63824-008-72 | 63824000872 | 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-72)Marketed from Jul 3, 2012 | |
| 63824-008-74 | 63824000874 | 24 POUCH in 1 CARTON (63824-008-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-73)Marketed from Jul 3, 2012 | |
| 63824-008-80 | 63824000880 | 4 BLISTER PACK in 1 CARTON (63824-008-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 | |
| 63824-008-86 | 63824000886 | 4 BLISTER PACK in 1 CARTON (63824-008-86) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 | |
| 63824-008-92 | 63824000892 | 6 BLISTER PACK in 1 CARTON (63824-008-92) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 3, 2012 |
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)
- Mucinex
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Reckitt Benckiser LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021282
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 63824-008_52d1138d-fffb-7c33-e063-6294a90ac171SPL ID 52d1138d-fffb-7c33-e063-6294a90ac171SPL set ID dd379cdd-90ab-42e0-ad89-f50d3220f611RxCUI 636522, 891301UNII 495W7451VQUPC 0363824008202
- 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
N463824000815followed by a unit qualifier and the quantityPackage 63824-0008-15. 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 NDA 021282
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 |
|---|---|---|---|---|
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-149 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-954 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-0818 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 68084-572 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6078 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Cardinal Health 107, LLC | 55154-4680 |
| Mucinex Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-2301 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-2380 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-7115 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | ATLANTIC BIOLOGICAS CORP. | 17856-0008 |
| Mucinex Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Reckitt Benckiser LLC | 63824-023 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1340 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-7886 |