Over-the-counter drug · ANDA

Mucus D NDC 51316-878

guaifenesin and pseudoephedrine hydrochloride · Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 · Tablet, Multilayer, Extended release · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

NDC codes

FDA NDC Directory
Product NDC (as listed)51316-878Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0878Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51316-878-68513160878682 BLISTER PACK in 1 CARTON (51316-878-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 4, 2025
51316-878-89513160878891 BLISTER PACK in 1 CARTON (51316-878-89) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 4, 2025

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)
Mucus 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
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 51316-878_0468ceb2-2ea4-4178-8eb7-a9e48320308cSPL ID 0468ceb2-2ea4-4178-8eb7-a9e48320308c
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

N451316087868 followed by a unit qualifier and the quantity

Package 51316-0878-68. 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.

Other NDCs under ANDA 214407

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214407
ProductStrengthForm · routeLabelerProduct NDC
mucus dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralKroger Company30142-739
Mucus Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralMeijer, Inc.79481-0709
mucus Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-8307
Mucus Dguaifenesin, pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-8911
mucus relief dguaifenesin, pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralH E B59640-300
mucus dguaifenesin, pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-345
mucus relief dguaifenesin, pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralWalgreen Company0363-2389
mucus relief dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralH E B59640-621
Mucus Relief Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralWalgreen Company0363-8708
Equate Mucus Dguaifenesin, pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralWALMART INC.79903-388
topcare mucus dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralTopco Associates LLC76162-801
equate mucus dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralWALMART INC.79903-125
Rugby Mucus Relief Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralRugby Laboratories0536-1449
nasal and chest decongestantguaifenesin, pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralPublix Super Markets Inc56062-614
Leader Mucus Relief Dguaifenesin, pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0719
Leader Mucus Relief Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0720
mucus Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralMeijer, Inc.79481-0119
foster and thrive mucus relief dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Multilayer, Extended releaseOralStrategic Sourcing Services LLC70677-1272
foster and thrive mucus relief dguaifenesin, pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralStrategic Sourcing Services LLC70677-1273

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