Over-the-counter drug · ANDA
Rugby Mucus Relief D NDC 0536-1449
guaifenesin and pseudoephedrine hydrochloride · Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 · Tablet, Multilayer, Extended release · Oral · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1449-21 | 0053614492100536144921 | 1 BLISTER PACK in 1 CARTON (0536-1449-21) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 2, 2025 | |
| 0536-1449-36 | 0053614493600536144936 | 2 BLISTER PACK in 1 CARTON (0536-1449-36) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 2, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Rugby Mucus Relief D
- Generic name (nonproprietary)
- guaifenesin and pseudoephedrine hydrochloride
- Active ingredients
- Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
- Dosage form
- Tablet, Multilayer, Extended release
- Route
- Oral
- Labeler
- Rugby LaboratoriesNDC labeler code 0536
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214407
- 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 0536-1449_40a439ae-828a-4339-be4b-96b1ab32fd28SPL ID 40a439ae-828a-4339-be4b-96b1ab32fd28
- 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
N400536144921followed by a unit qualifier and the quantityPackage 00536-1449-21. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0536-1449
- What is NDC 0536-1449?
- 0536-1449 is the product NDC for Rugby Mucus Relief D, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, multilayer, extended release, listed with the FDA by Rugby Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rugby Mucus Relief D (Guaifenesin and pseudoephedrine hydrochloride).
- What is the active ingredient?
- Guaifenesin, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Rugby Laboratories, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rugby Mucus Relief D?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 214407
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 |
|---|---|---|---|---|
| equate mucus dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | WALMART INC. | 79903-125 |
| Equate Mucus Dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | WALMART INC. | 79903-388 |
| foster and thrive mucus relief dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1272 |
| foster and thrive mucus relief dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1273 |
| Leader Mucus Relief Dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0719 |
| Leader Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0720 |
| mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | L. Perrigo Company | 0113-8307 |
| Mucus Dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | L. Perrigo Company | 0113-8911 |
| mucus dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Kroger Company | 30142-739 |
| mucus dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-345 |
| Mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-878 |
| mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Meijer, Inc. | 79481-0119 |
| Mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Meijer, Inc. | 79481-0709 |
| mucus relief dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Walgreen Company | 0363-2389 |
| Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Walgreen Company | 0363-8708 |
| mucus relief dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | H E B | 59640-300 |
| mucus relief dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | H E B | 59640-621 |
| nasal and chest decongestantguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Publix Super Markets Inc | 56062-614 |
| topcare mucus dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Topco Associates LLC | 76162-801 |