Over-the-counter drug · ANDA

Mucus Relief (Guaifenesin) NDC 57344-203

Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · AAA Pharmaceutical, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)57344-203Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57344-0203Add 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
57344-203-0257344020302573440203022 BLISTER PACK in 1 CARTON (57344-203-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 1, 2024

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
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 600 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
AAA Pharmaceutical, Inc.NDC labeler code 57344
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 57344-203_1acb86a4-a4a9-7ccc-e063-6294a90a67edSPL ID 1acb86a4-a4a9-7ccc-e063-6294a90a67edSPL set ID 68d6b88a-85ed-414d-8369-c7cceb8e9780RxCUI 636522UNII 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

N457344020302 followed by a unit qualifier and the quantity

Package 57344-0203-02. 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)

About NDC 57344-203

What is NDC 57344-203?
57344-203 is the product NDC for Mucus Relief (guaifenesin), Guaifenesin 600 mg/1 tablet, extended release, listed with the FDA by AAA Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mucus Relief (Guaifenesin).
What is the active ingredient?
Guaifenesin.
Who is the labeler?
AAA Pharmaceutical, Inc., NDC labeler code 57344. 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?
70 other product NDCs are listed under this name. See all Mucus Relief NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Mucus Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Mucus ReliefguaifenesinGuaifenesin 400 mg/1TabletOralGeri-Care Pharmaceuticals, Corp57896-71857896-0718-01
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralYYBA Corp73581-40373581-0403-0173581-0403-03
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGrocery Outlet, Inc.85828-72385828-0723-02
mucus reliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-72851316-0728-5551316-0728-74
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralHYVEE INC42507-25342507-0253-03
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralPioneer Life Sciences, LLC72090-01172090-0011-0172090-0011-02
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralNUVICARE LLC84324-02684324-0026-01
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralPioneer Life Sciences, LLC72090-01272090-0012-0172090-0012-0272090-0012-03
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralNUVICARE LLC84324-03484324-0034-01
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAMERIFOODS TRADING COMPANY61504-20461504-0204-02

All 71 Mucus Relief NDCs

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/1TabletOralBi-Mart37835-408
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralBi-Mart37835-412
GuaifenesinGuaifenesin 1200 mg/1TabletOralWalgreens0363-0570
GuaifenesinGuaifenesin 600 mg/1TabletOralWalgreens0363-9569
GuaifenesinGuaifenesin 1200 mg/1TabletOralSAM'S WEST INC68196-405
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCVS PHARMACY, INC69842-335
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAdvanced Rx LLC80513-403
Good Sense Mucus ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-3650
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAdvanced Rx LLC80513-413
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralGranules India Ltd62207-569
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGranules India Ltd62207-570
Crcle Guaifenesin Extended-Release Tablets, 600 mgguaifenesin extended-releaseGuaifenesin 600 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-270
Crcle Guaifensin Extended Release Tablet, 1200 mgguaifensin extended-releaseGuaifenesin 1200 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-280
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-096
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-097
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralDemoulas Super Markets, Inc53942-203
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralDemoulas Super Markets, Inc53942-204
Maximum Strength Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-148
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGRANULES PHARMACEUTICALS INC.70010-199
12 Hour Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-149

Showing 20 of 39.

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