Over-the-counter drug · ANDA

Childrens Allergy Relief (Fexofenadine hcl) NDC 63548-0662

Fexofenadine hydrochloride 30 mg/1 · Tablet · Oral · PLD Acquisitions LLC DBA Avma Pharma Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)63548-0662Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63548-0662Add 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
63548-0662-56354806620563548066205500 TABLET in 1 BOTTLE, PLASTIC (63548-0662-5)Marketed from Oct 1, 2019

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)
Childrens Allergy Relief
Generic name (nonproprietary)
fexofenadine hcl
Active ingredients
Fexofenadine hydrochloride — 30 mg/1
Dosage form
Tablet
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204097
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63548-0662_ad1479f7-87d7-489b-aff5-e547de25edfeSPL ID ad1479f7-87d7-489b-aff5-e547de25edfeSPL set ID 052d6191-1d9c-45c9-8c81-d19a977eded5RxCUI 997488UNII 2S068B75ZU
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

N463548066205 followed by a unit qualifier and the quantity

Package 63548-0662-05. 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63548-0662

What is NDC 63548-0662?
63548-0662 is the product NDC for Childrens Allergy Relief (fexofenadine hcl), Fexofenadine hydrochloride 30 mg/1 tablet, listed with the FDA by PLD Acquisitions LLC DBA Avma Pharma Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Allergy Relief (Fexofenadine HCL).
What is the active ingredient?
Fexofenadine hydrochloride.
Who is the labeler?
PLD Acquisitions LLC DBA Avma Pharma Solutions, NDC labeler code 63548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Allergy Relief?
43 other product NDCs are listed under this name. See all Childrens Allergy Relief 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 Childrens Allergy Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralAmazon.com Services LLC72288-53372288-0533-34
Childrens Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 12.5 mg/5mLSolutionOralWALMART INC.79903-41179903-0411-0479903-0411-08
childrens allergy relieffluticasone propionateFluticasone propionate 50 ug/1Spray, MeteredNasalCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-81851316-0818-08
Childrens Allergy ReliefloratadineLoratadine 5 mg/5mLSolutionOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-61151316-0611-34
childrens allergy relieffluticasone propionateFluticasone propionate 50 ug/1Spray, MeteredNasalSafeway21130-60721130-0607-08
Childrens Allergy ReliefDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralAllegiant Health69168-47169168-0471-59
Childrens Allergy Reliefdiphenhydramine hclDiphenhydramine HCl 12.5 mg/5mLSolutionOralBest Choice63941-50563941-0505-26
Childrens Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 12.5 mg/5mLSolutionOralCardinal Health 110, LLC. DBA Leader70000-070170000-0701-01
childrens allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralSafeway21130-46521130-0465-34
Childrens Allergy Relieffluticasone propionateFluticasone propionate 50 ug/1Spray, MeteredNasalWalgreen Company0363-402300363-4023-08

All 44 Childrens Allergy Relief NDCs

Other NDCs under ANDA 204097

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

FDA NDC Directory listings under ANDA 204097
ProductStrengthForm · routeLabelerProduct NDC
24HR Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCARDINAL HEALTH 110, LLC. DBA LEADER70000-0726
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralA-S Medication Solutions50090-6965
equate allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralWalmart Inc.49035-366
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralA-S Medication Solutions50090-4070
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralWalmart Inc.79903-358
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralCamber Consumer Care69230-300
Fexofenadine HCLFexofenadine hydrochloride 60 mg/1TabletOralCamber Consumer Care69230-301
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralA-S Medication Solutions50090-4267
Allergy Relieffexofenadine hclFexofenadine hydrochloride 60 mg/1Tablet, CoatedOralPLD Acquisitions LLC DBA Avma Pharma Solutions63548-0663
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralPLD Acquisitions LLC DBA Avma Pharma Solutions63548-0664
Equatefexofenadine hydrochloride tabletsFexofenadine hydrochloride 180 mg/1TabletOralWalmart Inc79903-441
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralNorthwind Health Company, LLC51655-854
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralBryant Ranch Prepack71335-1217
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralProficient Rx LP71205-531
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralNorthStar RxLLC16714-899
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralYYBA Corp73581-009
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralStrategic Sourcing Services70677-1256
Fexofenadine HCLFexofenadine hydrochloride 60 mg/1TabletOralYYBA Corp73581-010
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-196
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-7449

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