NDC codes

FDA NDC Directory
Product NDC (as listed)47335-724Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0724Add 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
47335-724-64473350724646 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)Marketed from Mar 1, 2018
47335-724-66473350724662 BLISTER PACK in 1 CARTON (47335-724-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)Marketed from Mar 1, 2018
47335-724-75473350724754 BLISTER PACK in 1 CARTON (47335-724-75) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60)Marketed from Mar 1, 2018
47335-724-834733507248330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83)Marketed from Mar 1, 2018
47335-724-94473350724941 BLISTER PACK in 1 CARTON (47335-724-94) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2018
47335-724-95473350724953 BLISTER PACK in 1 CARTON (47335-724-95) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2018
47335-724-99473350724992 BLISTER PACK in 1 CARTON (47335-724-99) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2018

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)
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Generic name (nonproprietary)
fexofenadine hydrochloride and pseudoephedrine hydrochloride
Active ingredients
Fexofenadine hydrochloride — 60 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090818
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 47335-724_554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8SPL ID 554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8SPL set ID 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1RxCUI 997406UNII 2S068B75ZU, 6V9V2RYJ8NUPC 0347335724837
Pharmacologic class
Histamine-1 Receptor Antagonist; 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

N447335072464 followed by a unit qualifier and the quantity

Package 47335-0724-64. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 090818

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

FDA NDC Directory listings under ANDA 090818
ProductStrengthForm · routeLabelerProduct NDC
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralPUBLIX SUPER MARKETS, INC41415-995
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralAmeriSource Bergen46122-694
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralOhm Laboratories Inc.51660-037
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralH E B37808-999
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralwalgreens0363-2110
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralCVS Pharmacy69842-973
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy69842-990

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