NDC codes

FDA NDC Directory
Product NDC (as listed)55111-798Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0798Add 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
55111-798-0955111079809551110798091 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 29, 2017
55111-798-1855111079818551110798182 BLISTER PACK in 1 CARTON (55111-798-18) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 29, 2017
55111-798-3555111079835551110798351 BLISTER PACK in 1 CARTON (55111-798-35) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 23, 2020
55111-798-3655111079836551110798364 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 29, 2017
55111-798-4155111079841551110798412 BLISTER PACK in 1 CARTON (55111-798-41) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 11, 2020

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 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
Dr. Reddys Laboratories LimitedNDC labeler code 55111
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 55111-798_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cdSPL ID 9e158de3-9d7a-e6f8-2e19-5ef46d33e8cdSPL set ID 845a2dcc-9069-3141-ae13-f2063f36d130RxCUI 1244675, 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

N455111079809 followed by a unit qualifier and the quantity

Package 55111-0798-09. 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 55111-798

What is NDC 55111-798?
55111-798 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 Dr. Reddys Laboratories Limited. It has 5 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?
Dr. Reddys Laboratories Limited, NDC labeler code 55111. 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 releaseOralRite Aid Corporation11822-004611822-0046-0111822-0046-02
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

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 releaseOralRite Aid Corporation11822-0046
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

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in