Over-the-counter drug · ANDA

Guaifenesin NDC 0363-0033

Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · WALGREEN CO.

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0033Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0033Add 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
0363-0033-01003630033011 BLISTER PACK in 1 CARTON (0363-0033-01) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 8, 2020
0363-0033-02003630033022 BLISTER PACK in 1 CARTON (0363-0033-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 8, 2020
0363-0033-03003630033033 BLISTER PACK in 1 CARTON (0363-0033-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 1, 2021

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 — 1200 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210453
Marketing start
Listing expires
Other FDA classes
Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 0363-0033_e5e90576-743d-4e41-8b6e-efa7fb5c9e4cSPL ID e5e90576-743d-4e41-8b6e-efa7fb5c9e4cSPL set ID 0c329d9f-8f1e-4b41-a03b-324e5d1b4ae2RxCUI 310621UNII 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

N400363003301 followed by a unit qualifier and the quantity

Package 00363-0033-01. 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)

Other NDCs under ANDA 210453

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

FDA NDC Directory listings under ANDA 210453
ProductStrengthForm · routeLabelerProduct NDC
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralVESPYR BRANDS LLC71179-002
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAurohealth LLC58602-853
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAurohealth LLC58602-857
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAurohealth LLC58602-864
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAurohealth LLC58602-865
Mucus Relief MaxguaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralBetter Living Brands, LLC21130-399
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralSam's West Inc68196-960
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC76162-031
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralWALGREEN CO.0363-0028
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralRITE AID CORPORATION11822-4260
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-561
365 Whole Foods Market GuaifenesinguaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralWhole Foods Market, Inc.42681-0057
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralBetter Living Brands LLC21130-179
GuaifenesinGuaifenesin 1200 mg/1Tablet, Extended releaseOralAurohealth LLC58602-811
GuaifenesinGuaifenesin 600 mg/1Tablet, Extended releaseOralAurohealth LLC58602-810

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