Over-the-counter drug · ANDA
Allergy Relief (Fexofenadine hcl) NDC 63548-0663
Fexofenadine hydrochloride 60 mg/1 · Tablet, Coated · Oral · PLD Acquisitions LLC DBA Avma Pharma Solutions
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63548-0663Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63548-0663Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63548-0663-5 | 63548066305 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (63548-0663-5)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)
- Allergy Relief
- Generic name (nonproprietary)
- fexofenadine hcl
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- PLD Acquisitions LLC DBA Avma Pharma SolutionsNDC labeler code 63548
- 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 63548-0663_12832954-b355-49a3-9f33-7cc163d16298SPL ID 12832954-b355-49a3-9f33-7cc163d16298SPL set ID 0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6fRxCUI 997501UNII 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
N463548066305followed by a unit qualifier and the quantityPackage 63548-0663-05. 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.
About NDC 63548-0663
- What is NDC 63548-0663?
- 63548-0663 is the product NDC for Allergy Relief (fexofenadine hcl), Fexofenadine hydrochloride 60 mg/1 tablet, coated, 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?
- 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 Allergy Relief?
- 263 other product NDCs are listed under this name. See all Allergy Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Allergy Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allergy Relieflevocetirizine dihydrochloride usp, 5 mg | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Topco Associates, LLC | 76162-915 | 76162-0915-3576162-0915-80 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-391 | 72288-0391-0172288-0391-78 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0771 | 70000-0771-0170000-0771-02 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-784 | 72288-0784-27 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer, Inc. | 79481-9723 | 79481-9723-01 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-434 | 75907-0434-0175907-0434-30 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | Kroger Company | 30142-856 | 30142-0856-62 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-040 | 84324-0040-01 |
| Allergy Reliefcetirizine tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | DISCOUNT DRUG MART, INC | 53943-130 | 53943-0130-1353943-0130-17 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-203 | 59726-0203-3859726-0203-54 |
Other NDCs under ANDA 204097
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 24HR Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0726 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0664 |
| Allergy Relief | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Allegiant Health | 69168-450 |
| Childrens Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 30 mg/1 | TabletOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0662 |
| equate allergy relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walmart Inc. | 49035-366 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NorthStar RxLLC | 16714-899 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | A-S Medication Solutions | 50090-4070 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | A-S Medication Solutions | 50090-4267 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | A-S Medication Solutions | 50090-6965 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-854 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7449 |
| Fexofenadine HCL | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Camber Consumer Care | 69230-301 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Strategic Sourcing Services | 70677-1256 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Proficient Rx LP | 71205-531 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1217 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-196 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA Corp | 73581-009 |
| Fexofenadine HCL | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA Corp | 73581-010 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walmart Inc. | 79903-358 |
| Goodmeds Non Drowsy Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-4202 |
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