Over-the-counter drug · ANDA
MAXIMUM STRENGTH Mucus D NDC 51316-970
guaifenesin and pseudoephedrine hydrochloride · Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-970-24 | 51316097024 | 1 BLISTER PACK in 1 CARTON (51316-970-24) / 24 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 10, 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)
- MAXIMUM STRENGTH Mucus D
- Generic name (nonproprietary)
- guaifenesin and pseudoephedrine hydrochloride
- Active ingredients
- Guaifenesin — 1200 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- CVS Pharmacy
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212542
- 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 51316-970_a47d8036-88c3-4b04-b257-90e65d2ce922SPL ID a47d8036-88c3-4b04-b257-90e65d2ce922SPL set ID 9a560b80-972c-4af5-8fe8-eaef0b0d83b3RxCUI 1244675UNII 495W7451VQ, 6V9V2RYJ8N
- 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
N451316097024followed by a unit qualifier and the quantityPackage 51316-0970-24. 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 ANDA 212542
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 HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories, Inc. | 51660-074 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories, Inc. | 51660-077 |
| Guaifenesin Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | RUGBY LABORATORIES, INC. | 0536-1333 |
| Guaifenesin Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Walgreen Company | 0363-9930 |
| Guaifenesin and Pseudoephedrine Hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | STRATEGIC SOURCING SERVICES LLC | 62011-0475 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1263 |
| Guaifenesin Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 51316-993 |
| Guaifenesin and Pseudoephedrine Hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | PUBLIX SUPER MARKETS, INC | 41415-994 |