Over-the-counter drug · ANDA

Guaifenesin NDC 0363-9569

Guaifenesin 600 mg/1 · Tablet · Oral · Walgreens

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-9569Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-9569Add 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
0363-9569-02003639569020036395690220 TABLET in 1 BLISTER PACK (0363-9569-02)Marketed from Jul 19, 2024
0363-9569-04003639569040036395690440 TABLET in 1 BLISTER PACK (0363-9569-04)Marketed from Jul 19, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary)
guaifenesin
Active ingredients
Guaifenesin — 600 mg/1
Dosage form
Tablet
Route
Oral
Labeler
WalgreensNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213420
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 0363-9569_46546a5a-8f8f-e73a-e063-6394a90a8330SPL ID 46546a5a-8f8f-e73a-e063-6394a90a8330SPL set ID fd91621b-c969-8851-e053-6294a90ad8b2RxCUI 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

N400363956902 followed by a unit qualifier and the quantity

Package 00363-9569-02. 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

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 0363-9569

What is NDC 0363-9569?
0363-9569 is the product NDC for Guaifenesin, Guaifenesin 600 mg/1 tablet, listed with the FDA by Walgreens. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guaifenesin.
What is the active ingredient?
Guaifenesin.
Who is the labeler?
Walgreens, NDC labeler code 0363. 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?
63 other product NDCs are listed under this name. See all Guaifenesin 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralINNOVUS PHARMACEUTICALS, INC.57483-14457483-0144-28
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAurohealth LLC58602-85758602-0857-93
Guaifenesinguaifenesin 400 mgGuaifenesin 400 mg/1TabletOralZennova LLC81993-00281993-0002-0181993-0002-0281993-0002-03+2 more
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC76162-03176162-0031-56
GuaifenesinGuaifenesin 600 mg/1TabletOralYYBA CORP73581-40073581-0400-0273581-0400-07
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralSam's West Inc68196-96068196-0960-56
GuaifenesinGuaifenesin 100 mg/5mLLiquidOralKESIN PHARMA CORPORATION81033-10281033-0102-16
GuaifenesinGuaifenesin 100 mg/5mLSolutionOralAmerican Health Packaging60687-85260687-0852-17
GuaifenesinGuaifenesin 200 mg/10mLSolutionOralAmerican Health Packaging60687-86360687-0863-56
GuaifenesinGuaifenesin 300 mg/15mLSolutionOralAmerican Health Packaging60687-87460687-0874-16

All 64 Guaifenesin NDCs

Other NDCs under ANDA 213420

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

FDA NDC Directory listings under ANDA 213420
ProductStrengthForm · routeLabelerProduct NDC
Mucus ReliefguaifenesinGuaifenesin 600 mg/1TabletOralBi-Mart37835-408
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralBi-Mart37835-412
GuaifenesinGuaifenesin 1200 mg/1TabletOralWalgreens0363-0570
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-203
GuaifenesinGuaifenesin 1200 mg/1TabletOralSAM'S WEST INC68196-405
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCVS PHARMACY, INC69842-335
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAdvanced Rx LLC80513-403
Good Sense Mucus ERguaifenesinGuaifenesin 1200 mg/1Tablet, Multilayer, Extended releaseOralL. Perrigo Company0113-3650
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAdvanced Rx LLC80513-413
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralGranules India Ltd62207-569
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGranules India Ltd62207-570
Crcle Guaifenesin Extended-Release Tablets, 600 mgguaifenesin extended-releaseGuaifenesin 600 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-270
Crcle Guaifensin Extended Release Tablet, 1200 mgguaifensin extended-releaseGuaifenesin 1200 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-280
Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-096
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-097
Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralDemoulas Super Markets, Inc53942-203
Mucus Relief Maximum StrengthguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralDemoulas Super Markets, Inc53942-204
Maximum Strength Mucus ReliefguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-148
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralGRANULES PHARMACEUTICALS INC.70010-199
12 Hour Mucus ReliefguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-149

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