Over-the-counter drug · ANDA
fexofenadine hcl NDC 50228-201
Fexofenadine hydrochloride 60 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-201-01 | 50228020101 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-01)Marketed from Dec 26, 2014 | |
| 50228-201-02 | 50228020102 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-02)Marketed from Dec 26, 2014 | |
| 50228-201-03 | 50228020103 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-03)Marketed from Dec 26, 2014 | |
| 50228-201-04 | 50228020104 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-04)Marketed from Dec 26, 2014 |
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 hcl
- Generic name (nonproprietary)
- fexofenadine hcl
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204507
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50228-201_2a0b48b8-5955-9ab7-e063-6394a90a6b24SPL ID 2a0b48b8-5955-9ab7-e063-6394a90a6b24SPL set ID b7e9477d-33d9-4463-b8a6-69af5f71ce35RxCUI 997420, 997501UNII 2S068B75ZUUPC 0350228202015, 0350228201032, 0350228202022, 0350228201025, 0350228201018, 0350228202046, 0350228201049, 0350228202039
- 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
N450228020101followed by a unit qualifier and the quantityPackage 50228-0201-01. 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 reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204507
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 |
|---|---|---|---|---|
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | SPIRIT PHARMACEUTICALS LLC | 68210-2210 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | SPIRIT PHARMACEUTICALS LLC | 68210-4090 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Advanced Rx LLC | 80513-506 |
| Gencare-Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-068 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-202 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2165 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Capsule, CoatedOral | Allegiant Health | 69168-416 |
| Curist Allergy Relieffexofenadine hydrochloride 180 mg | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Little Pharma, Inc. | 72559-027 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Bi-Mart | 37835-601 |
| Curist Hives Relieffexofenadine hydrochloride 180 mg | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Little Pharma, Inc. | 72559-028 |
| Fexofenadine Hydrochloridefexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-231 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Akron Pharma Inc. | 71399-8042 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | AKRON PHARMA INC | 71399-8659 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-893 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-905 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA CORP | 73581-011 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Magno-Humphries, Inc. | 54257-170 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA CORP | 73581-103 |
| Fexofenadine HCl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Camber Consumer Care | 69230-201 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Camber Consumer Care | 69230-202 |
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