NDC codes

FDA NDC Directory
Product NDC (as listed)0363-9930Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-9930Add 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
0363-9930-1800363993018003639930181 BLISTER PACK in 1 CARTON (0363-9930-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 6, 2021
0363-9930-3600363993036003639930362 BLISTER PACK in 1 CARTON (0363-9930-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 6, 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 D
Generic name (nonproprietary)
guaifenesin and pseudoephedrine hydrochloride
Active ingredients
Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Walgreen CompanyNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212542
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 0363-9930_a170c33d-402e-447f-ad46-402c60045461SPL ID a170c33d-402e-447f-ad46-402c60045461SPL set ID abecb791-b635-482f-bb99-3ee4b7093e78RxCUI 1305603UNII 495W7451VQ, 6V9V2RYJ8N
Pharmacologic class
Expectorant; alpha-Adrenergic Agonist

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

N400363993018 followed by a unit qualifier and the quantity

Package 00363-9930-18. 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 temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0363-9930

What is NDC 0363-9930?
0363-9930 is the product NDC for Guaifenesin D, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, extended release, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guaifenesin D (Guaifenesin and Pseudoephedrine Hydrochloride).
What is the active ingredient?
Guaifenesin, Pseudoephedrine hydrochloride.
Who is the labeler?
Walgreen Company, 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 D?
2 other product NDCs are listed under this name. See all Guaifenesin D 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 D NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Guaifenesin Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralRUGBY LABORATORIES, INC.0536-133300536-1333-2100536-1333-36
Guaifenesin Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralCVS Pharmacy, Inc.51316-99351316-0993-1851316-0993-36

Other NDCs under ANDA 212542

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

FDA NDC Directory listings under ANDA 212542
ProductStrengthForm · routeLabelerProduct NDC
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralOhm Laboratories, Inc.51660-074
Guaifenesin and Pseudoephedrine HClGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralOhm Laboratories, Inc.51660-077
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralStrategic Sourcing Services LLC70677-1263
Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralPUBLIX SUPER MARKETS, INC41415-994
Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC62011-0475
Guaifenesin Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralRUGBY LABORATORIES, INC.0536-1333
Guaifenesin Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralCVS Pharmacy, Inc.51316-993
MAXIMUM STRENGTH Mucus Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-970

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