Over-the-counter drug · ANDA

Mucus Relief Maximum Strength (guaifenesin) NDC 53942-204

Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Demoulas Super Markets, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)53942-204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53942-0204Add 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
53942-204-02539420204021 BLISTER PACK in 1 CARTON (53942-204-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 1, 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)
Mucus Relief Maximum StrengthSuffix: Maximum Strength
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 1200 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213420
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 53942-204_ea23a5a6-3f0f-41bb-e053-2a95a90a1f5cSPL ID ea23a5a6-3f0f-41bb-e053-2a95a90a1f5cSPL set ID e8948cbe-1ecc-490d-e053-2995a90a6ba1RxCUI 310621UNII 495W7451VQ
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

N453942020402 followed by a unit qualifier and the quantity

Package 53942-0204-02. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213420

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

FDA NDC Directory listings under ANDA 213420
ProductStrengthForm · routeLabelerProduct NDC
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-203
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralPioneer Life Sciences, LLC72090-011
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralPioneer Life Sciences, LLC72090-012
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAdvanced Rx LLC80513-403
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAdvanced Rx LLC80513-413
basic care mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralAmazon.com Services LLC72288-650
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralDemoulas Super Markets, Inc53942-203
GuaifenesinGuaifenesin 1200 mg/1TabletOralSafeway, Inc21130-554
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralGranules India Ltd62207-569
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCVS PHARMACY, INC69842-335
Good Sense Mucus ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-3650
Crcle Guaifenesin Extended-Release Tablets, 600 mgguaifenesin extended-releaseGuaifenesin 600 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-270
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGranules India Ltd62207-570
Crcle Guaifensin Extended Release Tablet, 1200 mgguaifensin extended-releaseGuaifenesin 1200 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-280
GuaifenesinGuaifenesin 1200 mg/1TabletOralWalgreens0363-0570
Betr chest congestion reliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralLive Betr LLC80267-002
Betr remedies chest congestion reliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralLive Betr LLC80267-010
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGranules India Ltd62207-839
GuaifenesinGuaifenesin 1200 mg/1TabletOralTARGET CORPORATION11673-840
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralGranules India Ltd62207-840

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