Over-the-counter drug · NDA
Mucinex D NDC 63824-057
guaifenesin and pseudoephedrine hydrochloride · Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 · Tablet, Extended release · Oral · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63824-057-18 | 63824005718 | 1 BLISTER PACK in 1 CARTON (63824-057-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-057-36 | 63824005736 | 4 BLISTER PACK in 1 CARTON (63824-057-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 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 D
- Generic name (nonproprietary)
- guaifenesin and pseudoephedrine hydrochloride
- Active ingredients
- Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 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 021585
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 63824-057_52d12ac7-93cd-3f6b-e063-6294a90aaa02SPL ID 52d12ac7-93cd-3f6b-e063-6294a90aaa02SPL set ID d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84fRxCUI 1305603UNII 495W7451VQ, 6V9V2RYJ8NUPC 0363824057187
- Pharmacologic class
- Expectorant; alpha-Adrenergic Agonist
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
N463824005718followed by a unit qualifier and the quantityPackage 63824-0057-18. 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 temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021585
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 and Pseudoephedrine Hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | WALGREEN COMPANY | 0363-0077 |
| Mucinex Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1075 |
| Mucinex Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1076 |
| Mucinex D Maximum Strengthguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Reckitt Benckiser LLC | 63824-041 |