NDC codes

FDA NDC Directory
Product NDC (as listed)51316-183Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0183Add 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
51316-183-005131601830051316018300180 TABLET in 1 BOTTLE (51316-183-00)Marketed from Oct 22, 2025

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)
CVS Fexofenadine Hydrochloride
Generic name (nonproprietary)
fexofenadine hydrochloride
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Tablet
Route
Oral
Labeler
CVS PharmacyNDC labeler code 51316
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210137
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 51316-183_41c5bbff-5362-e7e2-e063-6294a90a5fc2SPL ID 41c5bbff-5362-e7e2-e063-6294a90a5fc2SPL set ID 3d6c7b10-ed05-bbde-e063-6294a90ae92fRxCUI 997420UNII 2S068B75ZUUPC 0050428000618
Pharmacologic class
Histamine-1 Receptor Antagonist

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

N451316018300 followed by a unit qualifier and the quantity

Package 51316-0183-00. 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 • itchy, watery eyes • sneezing • itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51316-183

What is NDC 51316-183?
51316-183 is the product NDC for CVS Fexofenadine Hydrochloride (fexofenadine hydrochloride), Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by CVS Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
CVS Fexofenadine Hydrochloride (Fexofenadine hydrochloride).
What is the active ingredient?
Fexofenadine hydrochloride.
Who is the labeler?
CVS Pharmacy, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for CVS Fexofenadine Hydrochloride?
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 ANDA 210137

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

FDA NDC Directory listings under ANDA 210137
ProductStrengthForm · routeLabelerProduct NDC
FEXOFENADINE HClFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralStrategic Sourcing Services, LLC70677-1239
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralPioneer Life Sciences, LLC72090-010
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA Corp73581-027
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralNUVICARE LLC84324-008
Gencare Hives Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralPioneer Life Sciences, LLC72090-058
Nuvicare Hives Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralNUVICARE LLC84324-031

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