Over-the-counter drug · ANDA

Mucus Relief (Guaifenesin) NDC 55319-551

Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Family Dollar (FAMILY WELLNESS)

NDC codes

FDA NDC Directory
Product NDC (as listed)55319-551Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55319-0551Add 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
55319-551-0755319055107553190551077 BLISTER PACK in 1 CARTON (55319-551-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 1, 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)
Mucus Relief
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 1200 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Family Dollar (FAMILY WELLNESS)NDC labeler code 55319
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207342
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 55319-551_eb96a48c-7f7c-4ddd-bdc7-f71b3d9c1321SPL ID eb96a48c-7f7c-4ddd-bdc7-f71b3d9c1321SPL set ID 1e1a9335-58ac-4722-9188-c847e62e7215RxCUI 310621UNII 495W7451VQUPC 0032251920820
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

N455319055107 followed by a unit qualifier and the quantity

Package 55319-0551-07. 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 makes coughs more productive.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55319-551

What is NDC 55319-551?
55319-551 is the product NDC for Mucus Relief (guaifenesin), Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Family Dollar (FAMILY WELLNESS). It has 1 package NDC, 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?
Family Dollar (FAMILY WELLNESS), NDC labeler code 55319. 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 207342

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

FDA NDC Directory listings under ANDA 207342
ProductStrengthForm · routeLabelerProduct NDC
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAmneal Pharmaceuticals LLC65162-036
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAmneal Pharmaceuticals LLC65162-037
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralRugby Laboratories0536-1392
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralRite Aid Corporation11822-3252
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralH E B37808-830
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralH E B37808-935
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-731
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralFamily Dollar (FAMILY WELLNESS)55319-733
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-739
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralP & L Development, LLC59726-237
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralP & L Development, LLC59726-734
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralBest Choice (Valu Merchandisers Company)63941-731
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralWinCo Foods, LLC67091-370
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralHarris Teeter, LLC69256-731
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralStrategic Sourcing Services LLC70677-1051
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralStrategic Sourcing Services LLC70677-1052
Mucus Relief ERguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-6718
Mucus Relief ERguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCardinal Health 107, LLC55154-4153
Mucus Relief Extended ReleaseguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralRugby Laboratories, Inc.0536-1163
Mucus Relief Extended ReleaseguaifenesinGuaifenesin 1200 mg/1TabletOralTARGET Corporation11673-732

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