Over-the-counter drug · ANDA

Crcle Guaifensin Extended Release Tablet, 1200 mg NDC 57483-280

guaifensin extended-release · Guaifenesin 1200 mg/1 · Tablet · Oral · Innovus Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)57483-280Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57483-0280Add 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
57483-280-02574830280024 BLISTER PACK in 1 CARTON (57483-280-02) / 14 TABLET in 1 BLISTER PACKMarketed from Apr 28, 2023

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)
Crcle Guaifensin Extended Release Tablet, 1200 mg
Generic name (nonproprietary)
guaifensin extended-release
Active ingredients
Guaifenesin — 1200 mg/1
Dosage form
Tablet
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 57483-280_77d8fc95-d94b-42f5-97ae-b5ff59ef638bSPL ID 77d8fc95-d94b-42f5-97ae-b5ff59ef638bSPL set ID bba4b91a-bea9-41be-9588-5fb1483c7d10RxCUI 310621, 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

N457483028002 followed by a unit qualifier and the quantity

Package 57483-0280-02. 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
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralDemoulas Super Markets, Inc53942-204
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
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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NDC 57483-280 | Med-Code