NDC codes

FDA NDC Directory
Product NDC (as listed)11822-0046Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11822-0046Add 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
11822-0046-111822004601118220046011 BLISTER PACK in 1 CARTON (11822-0046-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 1, 2022
11822-0046-211822004602118220046022 BLISTER PACK in 1 CARTON (11822-0046-2) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 1, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 and Pseudoephedrine HCl
Generic name (nonproprietary)
guaifenesin and pseudoephedrine hcl
Active ingredients
Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Rite Aid CorporationNDC labeler code 11822
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208369
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 11822-0046_a03e6b5b-fed4-dd64-160d-be1315e7ceceSPL ID a03e6b5b-fed4-dd64-160d-be1315e7ceceSPL set ID 9fb0c938-d24b-2371-95db-6c82d9511d72RxCUI 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

N411822004601 followed by a unit qualifier and the quantity

Package 11822-0046-01. 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)

Use(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some 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 11822-0046

What is NDC 11822-0046?
11822-0046 is the product NDC for Guaifenesin and Pseudoephedrine HCl, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, extended release, listed with the FDA by Rite Aid Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Guaifenesin and Pseudoephedrine HCl.
What is the active ingredient?
Guaifenesin, Pseudoephedrine hydrochloride.
Who is the labeler?
Rite Aid Corporation, NDC labeler code 11822. 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 and Pseudoephedrine HCl?
14 other product NDCs are listed under this name. See all Guaifenesin and Pseudoephedrine HCl 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 and Pseudoephedrine HCl NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralStrategic Sourcing Services LLC70677-126370677-1263-01
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralAmerisource Bergen46122-80146122-0801-08
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralGranules India Ltd62207-82762207-0827-72
Guaifenesin and Pseudoephedrine HClGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralGranules India Ltd62207-82862207-0828-71
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralWALGREEN CO.0363-994600363-9946-4000363-9946-45
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralMeijer79481-100279481-1002-01
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralKROGER COMPANY30142-13730142-0137-1230142-0137-17
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralOhm Laboratories, Inc.51660-07451660-0074-18
Guaifenesin and Pseudoephedrine HClGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralOhm Laboratories, Inc.51660-07751660-0077-12
Guaifenesin and Pseudoephedrine HClGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralWALGREEN CO.0363-013400363-0134-78

All 15 Guaifenesin and Pseudoephedrine HCl NDCs

Other NDCs under ANDA 208369

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

FDA NDC Directory listings under ANDA 208369
ProductStrengthForm · routeLabelerProduct NDC
Guaifenesin and Pseudoephedrine HCLGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralDr. Reddys Laboratories Limited55111-798
Guaifenesin and Pseudoephedrine HClGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralStrategic Sourcing Services, LLC70677-1011
Mucus Dguaifenesin 600 mg and pseudoephedrine hcl 60 mgGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralCVS Health Corp69842-095
Mucus Relief Dguaifenesin and pseudoephedrine hclGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralWalgreens Company0363-1604
Mucus Relief Dguaifenesin and pseudoephedrine hclGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralWalgreens Company0363-7064
Mucus Relief Dguaifenesin and pseudoephedrine hclGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralRite Aid Corporation11822-7399
Mucus Relief Dguaifenesin and pseudoephedrine hclGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralWal-mart Stores, Inc.49035-261
Mucus Relief Dguaifenesin and pseudoephedrine hclGuaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralCVS Health Corp69842-211

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