Over-the-counter drug · ANDA

Topcare Mucus ER (Guaifenesin) NDC 76162-523

Guaifenesin 1200 mg/1 · Tablet, Multilayer, Extended release · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)76162-523Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0523Add 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
76162-523-0176162052301761620523012 BLISTER PACK in 1 CARTON (76162-523-01) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 9, 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)
Topcare Mucus ER
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 1200 mg/1
Dosage form
Tablet, Multilayer, Extended release
Route
Oral
Labeler
Topco Associates LLCNDC labeler code 76162
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 76162-523_1f0b246c-473b-4a46-8eac-0a89bd5ce351SPL ID 1f0b246c-473b-4a46-8eac-0a89bd5ce351SPL set ID 916de841-b1eb-4f00-9e25-1d2e4ab0c6e9RxCUI 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

N476162052301 followed by a unit qualifier and the quantity

Package 76162-0523-01. 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 76162-523

What is NDC 76162-523?
76162-523 is the product NDC for Topcare Mucus ER (guaifenesin), Guaifenesin 1200 mg/1 tablet, multilayer, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Topcare Mucus ER (Guaifenesin).
What is the active ingredient?
Guaifenesin.
Who is the labeler?
Topco Associates LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topcare Mucus ER?
2 other product NDCs are listed under this name. See all Topcare Mucus ER 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 Topcare Mucus ER NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Topcare Mucus ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralTopco Associates LLC76162-40976162-0409-0176162-0409-74
Topcare mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralTopco Associates LLC76162-12376162-0123-5876162-0123-60

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 RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgguaifenesinGuaifenesin 600 mg/1TabletOralYYBA CORP73581-401
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 1200 mgguaifenesinGuaifenesin 1200 mg/1TabletOralYYBA CORP73581-402
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralPioneer Life Sciences, LLC72090-011
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralPioneer Life Sciences, LLC72090-012
GuaifenesinGuaifenesin 1200 mg/1TabletOralTARGET CORPORATION11673-840
dg health mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralDolgencorp Inc55910-626
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralHYVEE INC42507-253
Mucus ReliefGuaifenesin 600 mg/1Tablet, Extended releaseOralAllegiant Health69168-459
Mucus Relief Maximum Strengthmucus reliefGuaifenesin 1200 mg/1Tablet, Extended releaseOralAllegiant Health69168-460
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralMeijer79481-1204
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-203
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-204
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGRANULES USA, INC.69848-017
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralGRANULES USA, INC.69848-018
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAMERIFOODS TRADING COMPANY61504-204
basic care mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralAmazon.com Services LLC72288-650
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralNUVICARE LLC84324-026
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralNUVICARE LLC84324-034
Expectorant Guaifenesin Extended-ReleaseguaifenesinGuaifenesin 1200 mg/1TabletOralYET HEALTH GROUP LLC81179-007
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-403

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