Over-the-counter drug · ANDA

Guaifenesin Extended-Release 1200 mg (Guaifenesin) NDC 53041-234

Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Guardian Drug Company

NDC codes

FDA NDC Directory
Product NDC (as listed)53041-234Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53041-0234Add 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
53041-234-3753041023437530410234374 BLISTER PACK in 1 CARTON (53041-234-37) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2018
53041-234-4753041023447530410234476 BLISTER PACK in 1 CARTON (53041-234-47) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2018
53041-234-5853041023458530410234582 BLISTER PACK in 1 CARTON (53041-234-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2018

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 Extended-Release 1200 mg
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 1200 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Guardian Drug CompanyNDC labeler code 53041
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209215
Marketing start
Listing expires
Identifiers
Product ID 53041-234_8186c3e8-1ae5-459d-8771-ad2d1ae95387SPL ID 8186c3e8-1ae5-459d-8771-ad2d1ae95387SPL set ID 20f9e083-419d-429d-a570-24b312ed5d2aRxCUI 310621, 636522UNII 495W7451VQ

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

N453041023437 followed by a unit qualifier and the quantity

Package 53041-0234-37. 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)

USE(S) 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 53041-234

What is NDC 53041-234?
53041-234 is the product NDC for Guaifenesin Extended-Release 1200 mg, Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Guardian Drug Company. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guaifenesin Extended-Release 1200 mg (Guaifenesin).
What is the active ingredient?
Guaifenesin.
Who is the labeler?
Guardian Drug Company, NDC labeler code 53041. 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 Extended-Release 1200 mg?
1 other product NDC are listed under this name. See all Guaifenesin Extended-Release 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 Extended-Release 1200 mg NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Guaifenesin Extended Release 1200 mgguaifenesinGuaifenesin 1200 mg/1TabletOralTIME CAP LABORATORIES, INC.49483-72449483-0724-70

Other NDCs under ANDA 209215

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

FDA NDC Directory listings under ANDA 209215
ProductStrengthForm · routeLabelerProduct NDC
Equate Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralWal-Mart Stores, Inc.49035-284
Foster and Thrive Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralStrategic Sourcing Services LLC70677-1013
GuaifenesinGuaifenesin 600 mg/1TabletOralYYBA CORP73581-400
Guaifenesin Extended Release 600 mgguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralWal-Mart Stores, Inc.79903-271
Guaifenesin Extended-Release 600 mgguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGuardian Drug Company53041-233
Maximum Strength Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralStrategic Sourcing Services LLC70677-1320
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8637
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-6986
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralDiscount Drug Mart, Inc53943-233
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralMcKesson Corporation dba SKY Packaging63739-067
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2642
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-499
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralYYBA Corp73581-403
Mucus Relief 600 mgguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGuardian Drug Company53041-190
Mucus Relief MaxguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralDiscount Drug Mart, Inc53943-234
Mucus Relief Maximum Strength 1200 mgguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralGuardian Drug Company53041-191
Topco Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralTopco Associates, LLC36800-226

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