Over-the-counter drug · ANDA
Fexofenadine Hydrochloride NDC 68210-4090
Fexofenadine hydrochloride 180 mg/1 · Tablet, Film coated · Oral · SPIRIT PHARMACEUTICALS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68210-4090-1 | 6821040900168210409001 | 100 TABLET, FILM COATED in 1 PACKAGE (68210-4090-1)Marketed from Jul 2, 2020 |
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)
- Fexofenadine Hydrochloride
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- SPIRIT PHARMACEUTICALS LLCNDC labeler code 68210
- 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 68210-4090_292e4a33-9cc0-d8a2-e063-6394a90a50b3SPL ID 292e4a33-9cc0-d8a2-e063-6394a90a50b3SPL set ID 5307b7ef-0c22-4aae-a2f6-033d31032f55RxCUI 997420UNII 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
N468210409001followed by a unit qualifier and the quantityPackage 68210-4090-01. 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 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 68210-4090
- What is NDC 68210-4090?
- 68210-4090 is the product NDC for Fexofenadine Hydrochloride, Fexofenadine hydrochloride 180 mg/1 tablet, film coated, listed with the FDA by SPIRIT PHARMACEUTICALS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fexofenadine Hydrochloride.
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- SPIRIT PHARMACEUTICALS LLC, NDC labeler code 68210. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fexofenadine Hydrochloride?
- 42 other product NDCs are listed under this name. See all Fexofenadine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fexofenadine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fexofenadine Hydrochloridefexofenadine hydrochloride oral | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-427 | 58602-0427-2058602-0427-24 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | NUVICARE LLC | 84324-045 | 84324-0045-01 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA Corp | 73581-025 | 73581-0025-0173581-0025-0673581-0025-20 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA Corp | 73581-026 | 73581-0026-0173581-0026-1073581-0026-20 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA Corp | 73581-027 | 73581-0027-0173581-0027-0473581-0027-10+1 more |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | AMZ789 LLC | 73629-008 | 73629-0008-03 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-008 | 84324-0008-01 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | AMERISOURCE BERGEN | 46122-779 | 46122-0779-5846122-0779-6146122-0779-66 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-010 | 72090-0010-01 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Granules India Limited | 62207-889 | 62207-0889-4962207-0889-5162207-0889-60 |
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 |
|---|---|---|---|---|
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA CORP | 73581-011 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Bi-Mart | 37835-601 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals | 77771-201 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals | 77771-202 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA CORP | 73581-103 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Advanced Rx LLC | 80513-506 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | SPIRIT PHARMACEUTICALS LLC | 68210-2210 |
| Allergy Relief non drowsyfexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | MEIJER, INC. | 41250-506 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Capsule, CoatedOral | Allegiant Health | 69168-416 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-201 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-202 |
| IAllergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | Safeway, Inc. | 21130-405 |
| Gencare-Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-068 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2165 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | NUVICARE LLC | 84324-045 |
| 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 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-701 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7192 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Magno-Humphries, Inc. | 54257-170 |
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