Over-the-counter drug · ANDA
Fexofenadine Hydrochloride NDC 46122-779
Fexofenadine hydrochloride 180 mg/1 · Tablet, Film coated · Oral · AMERISOURCE BERGEN
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46122-779-58 | 4612207795846122077958 | 3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 14, 2024 | |
| 46122-779-61 | 4612207796146122077961 | 1 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from May 14, 2024 | |
| 46122-779-66 | 4612207796646122077966 | 1 BOTTLE in 1 CARTON (46122-779-66) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from May 14, 2024 |
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 Hydrochloride
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AMERISOURCE BERGENNDC labeler code 46122
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091567
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46122-779_76ea7e25-e968-4c78-9eca-ac960ad55985SPL ID 76ea7e25-e968-4c78-9eca-ac960ad55985SPL set ID 2a578643-adc1-44ca-83f2-9d48527bd3a4RxCUI 997420UNII 2S068B75ZUUPC 0346122779661
- 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
N446122077958followed by a unit qualifier and the quantityPackage 46122-0779-58. 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.
About NDC 46122-779
- What is NDC 46122-779?
- 46122-779 is the product NDC for Fexofenadine Hydrochloride, Fexofenadine hydrochloride 180 mg/1 tablet, film coated, listed with the FDA by AMERISOURCE BERGEN. It has 3 package NDCs, 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?
- AMERISOURCE BERGEN, NDC labeler code 46122. 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 | 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 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Granules India Limited | 62207-891 | 62207-0891-4962207-0891-5162207-0891-58 |
Other NDCs under ANDA 091567
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8648 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-800 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | OHM LABORATORIES INC. | 51660-998 |