NDC codes

FDA NDC Directory
Product NDC (as listed)50090-1203Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-1203Add 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
50090-1203-0500901203001 BLISTER PACK in 1 CARTON (50090-1203-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 28, 2014

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)
Allegra-D
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
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020786
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 50090-1203_a0388348-fc41-4d13-81ad-d8f25cd154d9SPL ID a0388348-fc41-4d13-81ad-d8f25cd154d9SPL set ID 705e1087-61cb-43c3-8675-f56626a1707bRxCUI 997406, 997512UNII 2S068B75ZU, 6V9V2RYJ8N
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

N450090120300 followed by a unit qualifier and the quantity

Package 50090-1203-00. 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 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-1203

What is NDC 50090-1203?
50090-1203 is the product NDC for Allegra-D, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Allegra-D (Fexofenadine hydrochloride and pseudoephedrine hydrochloride).
What is the active ingredient?
Fexofenadine hydrochloride, Pseudoephedrine hydrochloride.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Allegra-D?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 020786

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

FDA NDC Directory listings under NDA 020786
ProductStrengthForm · routeLabelerProduct NDC
Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochlorideFexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralChattem, Inc.41167-4310

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