Over-the-counter drug · ANDA

Leader Mucus Relief (Guaifenesin) NDC 70000-0758

Guaifenesin 600 mg/1 · Tablet, Multilayer, Extended release · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0758Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0758Add 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
70000-0758-1700000758011 BLISTER PACK in 1 CARTON (70000-0758-1) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 8, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Leader Mucus Relief
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 600 mg/1
Dosage form
Tablet, Multilayer, Extended release
Route
Oral
Labeler
Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
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 70000-0758_e2a1f2ff-1dd6-4505-b638-cf91bb93ee24SPL ID e2a1f2ff-1dd6-4505-b638-cf91bb93ee24SPL set ID ca735722-0baa-4c85-8311-17dbce915fc5RxCUI 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

N470000075801 followed by a unit qualifier and the quantity

Package 70000-0758-01. 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 70000-0758

What is NDC 70000-0758?
70000-0758 is the product NDC for Leader Mucus Relief (guaifenesin), Guaifenesin 600 mg/1 tablet, multilayer, extended release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader Mucus Relief (Guaifenesin).
What is the active ingredient?
Guaifenesin.
Who is the labeler?
Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leader Mucus Relief?
1 other product NDC are listed under this name. See all Leader 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 Leader Mucus Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Leader Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-072170000-0721-01

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
up and up mucus reliefguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralTarget Corporation11673-421
Rugby Mucus Relief ERguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralRugby Laboratories0536-1489
Mucus And Chest CongestionguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-299
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
mucus extended releaseguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-400
Leader Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0721
basic care mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralAmazon.com Services LLC72288-298
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-470
Guaifenesin Extended-ReleaseguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralPrecision Dose Inc.68094-048
Rugby Mucus Relief ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralRugby Laboratories0536-1451
Up And Up Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralTarget Corporation82442-503
Mucus And Chest CongestionguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-520
good sense mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralRedpharm Drug67296-2223
Topcare mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralTopco Associates LLC76162-123
DG health mucus er maxguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralDolgencorp Inc55910-887
mucus erguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralHyVee Inc42507-202
foster and thrive mucus reliefguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralStrategic Sourcing Services LLC70677-1291
DG Health Mucus ERguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralDolgencorp, LLC55910-904
mucusguaifenesinGuaifenesin 600 mg/1Tablet, Multilayer, Extended releaseOralCVS Pharmacy69842-806

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