Over-the-counter drug · NDA
Mucinex Maximum Strength (Guaifenesin) NDC 63824-023
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63824-023-02 | 63824002302 | 1 POUCH in 1 CARTON (63824-023-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCHMarketed from Jul 1, 2021 | |
| 63824-023-07 | 63824002307 | 1 BLISTER PACK in 1 CARTON (63824-023-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 11, 2015 | |
| 63824-023-35 | 63824002335 | 1 BLISTER PACK in 1 CARTON (63824-023-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-023-36 | 63824002336 | 2 BLISTER PACK in 1 CARTON (63824-023-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-023-46 | 63824002346 | 3 BLISTER PACK in 1 CARTON (63824-023-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-023-48 | 63824002348 | 4 BLISTER PACK in 1 CARTON (63824-023-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-023-56 | 63824002356 | 4 BLISTER PACK in 1 CARTON (63824-023-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 1, 2021 |
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 Maximum StrengthSuffix: Maximum Strength
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Reckitt Benckiser LLCNDC labeler code 63824
- 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 63824-023_52d0f6be-a3c0-c950-e063-6294a90a5784SPL ID 52d0f6be-a3c0-c950-e063-6294a90a5784SPL set ID 47f5323c-ee3a-400d-b133-31d9c286fafdRxCUI 310621, 891297UNII 495W7451VQUPC 0363824023144
- 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
N463824002302followed by a unit qualifier and the quantityPackage 63824-0023-02. 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.
About NDC 63824-023
- What is NDC 63824-023?
- 63824-023 is the product NDC for Mucinex Maximum Strength (guaifenesin), Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Reckitt Benckiser LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucinex Maximum Strength (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Reckitt Benckiser LLC, NDC labeler code 63824. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mucinex Maximum Strength?
- 1 other product NDC are listed under this name. See all Mucinex Maximum Strength NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mucinex Maximum Strength products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mucinex Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-2301 | 50090-2301-01 |
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 | Proficient Rx LP | 63187-954 |
| 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 | 50090-0818 |
| 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 | Reckitt Benckiser LLC | 63824-008 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | ATLANTIC BIOLOGICAS CORP. | 17856-0008 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1340 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-149 |
| Mucinexguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-7886 |