Over-the-counter drug · ANDA

mucus relief (Guaifenesin) NDC 41250-684

Guaifenesin 600 mg/1 · Tablet, Multilayer, Extended release · Oral · Meijer Distribution Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)41250-684Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41250-0684Add 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
41250-684-0241250068402412500684025 BLISTER PACK in 1 CARTON (41250-684-02) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 15, 2021
41250-684-5841250068458412500684581 BOTTLE in 1 CARTON (41250-684-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 19, 2020
41250-684-6041250068460412500684601 BOTTLE in 1 CARTON (41250-684-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 7, 2020

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, Multilayer, Extended release
Route
Oral
Labeler
Meijer Distribution IncNDC labeler code 41250
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078912
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 41250-684_cf3b00e6-d0ec-4fec-a44c-34b9f619a17dSPL ID cf3b00e6-d0ec-4fec-a44c-34b9f619a17d
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

N441250068402 followed by a unit qualifier and the quantity

Package 41250-0684-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 41250-684

What is NDC 41250-684?
41250-684 is the product NDC for mucus relief (guaifenesin), Guaifenesin 600 mg/1 tablet, multilayer, extended release, listed with the FDA by Meijer Distribution Inc. It has 3 package NDCs, 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?
Meijer Distribution Inc, NDC labeler code 41250. 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 078912

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

FDA NDC Directory listings under ANDA 078912
ProductStrengthForm · routeLabelerProduct NDC
basic care mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralAmazon.com Services LLC72288-298
basic care mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralAmazon.com Services LLC72288-613
DG Health Mucus ERguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralDolgencorp, LLC55910-904
DG health mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralDolgencorp Inc55910-887
equate mucus reliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralWALMART INC.79903-327
equate mucus-erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralWALMART INC.79903-292
foster and thrive mucus reliefguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralStrategic Sourcing Services LLC70677-1291
Good Neighbor Pharmacy Mucus ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralAmerisource Bergen46122-814
good sense mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-2023
Good Sense Mucus ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-4077
good sense mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralRedpharm Drug67296-2223
Guaifenesin Extended-ReleaseguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralPrecision Dose Inc.68094-048
Leader Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0721
Leader Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0758
mucusguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCVS Pharmacy69842-806
Mucus And Chest CongestionguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-299
Mucus And Chest CongestionguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-520
mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralHyVee Inc42507-202
mucus erguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralHyVee Inc42507-471
mucus extended releaseguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-400

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