NDC codes

FDA NDC Directory
Product NDC (as listed)25000-041Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25000-0041Add 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
25000-041-122500000411225000004112500 TABLET in 1 BOTTLE (25000-041-12)Marketed from Aug 23, 2023
25000-041-3425000004134250000041342 BLISTER PACK in 1 CARTON (25000-041-34) / 14 TABLET in 1 BLISTER PACKMarketed from Apr 18, 2025
25000-041-7525000004175250000041752 BLISTER PACK in 1 CARTON (25000-041-75) / 6 TABLET in 1 BLISTER PACKMarketed from Aug 23, 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)
Guaifenesin 1200 mg
Generic name (nonproprietary)
guaifenesin 1200 mg
Active ingredients
Guaifenesin — 1200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
MARKSANS PHARMA LIMITEDNDC labeler code 25000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217780
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 25000-041_0af3bdb4-c1f3-4941-a1de-6e08c49849cbSPL ID 0af3bdb4-c1f3-4941-a1de-6e08c49849cbSPL set ID fedf43d0-d6d1-4f50-bbab-396701e45cb2RxCUI 310621, 636522UNII 495W7451VQUPC 0325000042127, 0325000041120, 0325000042554, 0325000041342, 0325000041755, 0325000042011, 0325000042998
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

N425000004112 followed by a unit qualifier and the quantity

Package 25000-0041-12. 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)

INDICATIONS & USAGE SECTION 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 25000-041

What is NDC 25000-041?
25000-041 is the product NDC for Guaifenesin 1200 mg, Guaifenesin 1200 mg/1 tablet, listed with the FDA by MARKSANS PHARMA LIMITED. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guaifenesin 1200 mg.
What is the active ingredient?
Guaifenesin.
Who is the labeler?
MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 1200 mg?
2 other product NDCs are listed under this name. See all Guaifenesin 1200 mg 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 1200 mg NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Guaifenesin 1200 mgguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralDr. Reddy's Laboratories Inc.43598-10843598-0108-37
Guaifenesin 1200 mgguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralStrategic Sourcing Services, LLC70677-125870677-1258-01

Other NDCs under ANDA 217780

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

FDA NDC Directory listings under ANDA 217780
ProductStrengthForm · routeLabelerProduct NDC
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralBJWC (Berkley & Jensen / BJ's)68391-724
Maximum Strength Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralSAM'S WEST INC68196-033
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGrocery Outlet, Inc.85828-723
Mucus Relief ERguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralRugby Laboratories0536-1249
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-724
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-723
Maximum Strength Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-724
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralLEADER/ Cardinal Health 110, Inc.70000-0730
Guaifenesin Extended Release 600 mgguaifenesinGuaifenesin 600 mg/1TabletOralTIME CAP LABORATORIES, INC.49483-723
Guaifenesin Extended Release 1200 mgguaifenesinGuaifenesin 1200 mg/1TabletOralTIME CAP LABORATORIES, INC.49483-724
Guaifenesin 600 mgGuaifenesin 600 mg/1TabletOralMARKSANS PHARMA LIMITED25000-042

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