Over-the-counter drug · ANDA

Guaifenesin NDC 58602-853

Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Aurohealth LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)58602-853Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58602-0853Add 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
58602-853-1258602085312586020853121 BOTTLE in 1 CARTON (58602-853-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 13, 2020
58602-853-2158602085321586020853211 BOTTLE in 1 CARTON (58602-853-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 13, 2020
58602-853-7358602085373586020853731 BOTTLE in 1 CARTON (58602-853-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 13, 2020
58602-853-9658602085396586020853961 BLISTER PACK in 1 CARTON (58602-853-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 13, 2020
58602-853-9758602085397586020853972 BLISTER PACK in 1 CARTON (58602-853-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 13, 2020
58602-853-9858602085398586020853985 BLISTER PACK in 1 CARTON (58602-853-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 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)
Guaifenesin
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 600 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Aurohealth LLCNDC labeler code 58602
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210453
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 58602-853_af251c56-1fce-46a6-bd52-cca3425b96f9SPL ID af251c56-1fce-46a6-bd52-cca3425b96f9SPL set ID 84117b6e-4eeb-42b0-90b1-331f70d5a175RxCUI 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

N458602085312 followed by a unit qualifier and the quantity

Package 58602-0853-12. 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 58602-853

What is NDC 58602-853?
58602-853 is the product NDC for Guaifenesin, Guaifenesin 600 mg/1 tablet, extended release, listed with the FDA by Aurohealth LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guaifenesin.
What is the active ingredient?
Guaifenesin.
Who is the labeler?
Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Guaifenesin?
63 other product NDCs are listed under this name. See all Guaifenesin 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 Guaifenesin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralINNOVUS PHARMACEUTICALS, INC.57483-14457483-0144-28
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAurohealth LLC58602-85758602-0857-93
Guaifenesinguaifenesin 400 mgGuaifenesin 400 mg/1TabletOralZennova LLC81993-00281993-0002-0181993-0002-0281993-0002-03+2 more
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC76162-03176162-0031-56
GuaifenesinGuaifenesin 600 mg/1TabletOralYYBA CORP73581-40073581-0400-0273581-0400-07
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralSam's West Inc68196-96068196-0960-56
GuaifenesinGuaifenesin 100 mg/5mLLiquidOralKESIN PHARMA CORPORATION81033-10281033-0102-16
GuaifenesinGuaifenesin 100 mg/5mLSolutionOralAmerican Health Packaging60687-85260687-0852-17
GuaifenesinGuaifenesin 200 mg/10mLSolutionOralAmerican Health Packaging60687-86360687-0863-56
GuaifenesinGuaifenesin 300 mg/15mLSolutionOralAmerican Health Packaging60687-87460687-0874-16

All 64 Guaifenesin NDCs

Other NDCs under ANDA 210453

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

FDA NDC Directory listings under ANDA 210453
ProductStrengthForm · routeLabelerProduct NDC
365 Whole Foods Market GuaifenesinguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralWhole Foods Market, Inc.42681-0057
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralWALGREEN CO.0363-0028
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralWALGREEN CO.0363-0033
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralRITE AID CORPORATION11822-4260
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralBetter Living Brands LLC21130-179
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAurohealth LLC58602-810
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAurohealth LLC58602-811
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAurohealth LLC58602-857
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAurohealth LLC58602-864
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAurohealth LLC58602-865
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-561
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralSam's West Inc68196-960
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralVESPYR BRANDS LLC71179-002
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC76162-031
Mucus Relief MaxguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralBetter Living Brands, LLC21130-399

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in