Over-the-counter drug · ANDA
Mucus Relief D (Guaifenesin and pseudoephedrine hcl) NDC 0363-1604
Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 · Tablet, Extended release · Oral · Walgreens Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1604-15 | 0036316041500363160415 | 1 BLISTER PACK in 1 CARTON (0363-1604-15) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 30, 2020 | |
| 0363-1604-20 | 0036316042000363160420 | 2 BLISTER PACK in 1 CARTON (0363-1604-20) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 13, 2019 | |
| 0363-1604-37 | 0036316043700363160437 | 2 BLISTER PACK in 1 CARTON (0363-1604-37) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 30, 2020 | |
| 0363-1604-40 | 0036316044000363160440 | 4 BLISTER PACK in 1 CARTON (0363-1604-40) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 13, 2019 |
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)
- Mucus Relief D
- Generic name (nonproprietary)
- guaifenesin and pseudoephedrine hcl
- Active ingredients
- Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Walgreens CompanyNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208369
- 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 0363-1604_9a13bb97-fe92-b12e-9847-8546870add92SPL ID 9a13bb97-fe92-b12e-9847-8546870add92SPL set ID 01047716-389b-df25-ebe6-c897fc47d3dfRxCUI 1305603UNII 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
N400363160415followed by a unit qualifier and the quantityPackage 00363-1604-15. 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 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.
About NDC 0363-1604
- What is NDC 0363-1604?
- 0363-1604 is the product NDC for Mucus Relief D, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, extended release, listed with the FDA by Walgreens Company. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucus Relief D (Guaifenesin and Pseudoephedrine HCL).
- What is the active ingredient?
- Guaifenesin, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Walgreens Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mucus Relief D?
- 9 other product NDCs are listed under this name. See all Mucus Relief D NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mucus Relief D products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| mucus relief dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Walgreen Company | 0363-2389 | 00363-2389-62 |
| Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | Walgreen Company | 0363-8708 | 00363-8708-68 |
| mucus relief dguaifenesin, pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | H E B | 59640-300 | 59640-0300-62 |
| mucus relief dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Multilayer, Extended releaseOral | H E B | 59640-621 | 59640-0621-89 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Wal-mart Stores, Inc. | 49035-261 | 49035-0261-12 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-7399 | 11822-7399-0411822-7399-06 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Walgreens Company | 0363-7064 | 00363-7064-2400363-7064-30 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | CVS Health Corp | 69842-211 | 69842-0211-2469842-0211-28 |
| Mucus Relief Dguaifenesin, pseudoephedrine hcl | Guaifenesin 400 mg/1; Pseudoephedrine hydrochloride 40 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-547 | 41250-0547-72 |
Other NDCs under ANDA 208369
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 | Rite Aid Corporation | 11822-0046 |
| Guaifenesin and Pseudoephedrine HCL | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Dr. Reddys Laboratories Limited | 55111-798 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1011 |
| Mucus Dguaifenesin 600 mg and pseudoephedrine hcl 60 mg | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | CVS Health Corp | 69842-095 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Walgreens Company | 0363-7064 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-7399 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Wal-mart Stores, Inc. | 49035-261 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | CVS Health Corp | 69842-211 |