Over-the-counter drug · ANDA

MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg (Guaifenesin) NDC 73581-401

Guaifenesin 600 mg/1 · Tablet · Oral · YYBA CORP

NDC codes

FDA NDC Directory
Product NDC (as listed)73581-401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73581-0401Add 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
73581-401-027358104010273581040102200 TABLET in 1 BOTTLE (73581-401-02)Marketed from Mar 2, 2022
73581-401-20735810401207358104012020 TABLET in 1 BOTTLE (73581-401-20)Marketed from Nov 27, 2025
73581-401-70735810401707358104017070 TABLET in 1 BOTTLE (73581-401-70)Marketed from Jan 2, 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 RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgSuffix: GUAIFENESIN EXTENDED-RELEASE 600 mg
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 600 mg/1
Dosage form
Tablet
Route
Oral
Labeler
YYBA CORPNDC labeler code 73581
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 73581-401_4497c67f-376c-7ef0-e063-6294a90ad64aSPL ID 4497c67f-376c-7ef0-e063-6294a90ad64aSPL set ID d9d1ce2d-d96a-4950-e053-2995a90ad988RxCUI 636522UNII 495W7451VQUPC 0373581000159, 0373581000678
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

N473581040102 followed by a unit qualifier and the quantity

Package 73581-0401-02. 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 73581-401

What is NDC 73581-401?
73581-401 is the product NDC for MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg, Guaifenesin 600 mg/1 tablet, listed with the FDA by YYBA CORP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg (Guaifenesin).
What is the active ingredient?
Guaifenesin.
Who is the labeler?
YYBA CORP, NDC labeler code 73581. 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 GUAIFENESIN EXTENDED-RELEASE 600 mg?
1 other product NDC are listed under this name. See all MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg 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 GUAIFENESIN EXTENDED-RELEASE 600 mg NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgguaifenesinGuaifenesin 600 mg/1TabletOralTWIN MED LLC55681-30155681-0301-01

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
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-203
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

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