Over-the-counter drug · ANDA
Fexofenadine hydrochloride NDC 55111-783
Fexofenadine hydrochloride 60 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-783-01 | 5511107830155111078301 | 100 TABLET in 1 BOTTLE (55111-783-01)Marketed from Jan 3, 2011 | |
| 55111-783-24 | 5511107832455111078324 | 4 BLISTER PACK in 1 CARTON (55111-783-24) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020 | |
| 55111-783-28 | 5511107832855111078328 | 2 BLISTER PACK in 1 CARTON (55111-783-28) / 6 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020 | |
| 55111-783-60 | 5511107836055111078360 | 60 TABLET in 1 BOTTLE (55111-783-60)Marketed from Jan 3, 2011 | |
| 55111-783-78 | 5511107837855111078378 | 10 BLISTER PACK in 1 CARTON (55111-783-78) / 10 TABLET in 1 BLISTER PACK (55111-783-79)Marketed from Jan 3, 2011 | |
| 55111-783-90 | 5511107839055111078390 | 90 TABLET in 1 BOTTLE (55111-783-90)Marketed from Jan 3, 2011 |
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 — 60 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076502
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55111-783_c5d24cd6-8212-e647-78b1-27906e6f62bdSPL ID c5d24cd6-8212-e647-78b1-27906e6f62bdSPL set ID 864e3052-5787-bf11-9d17-11274ca2304fRxCUI 997420, 997488, 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
N455111078301followed by a unit qualifier and the quantityPackage 55111-0783-01. 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)
Use(s) 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 55111-783
- What is NDC 55111-783?
- 55111-783 is the product NDC for Fexofenadine hydrochloride, Fexofenadine hydrochloride 60 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 6 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?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 076502
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 | Rite Aid Corporation | 11822-3698 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Safeway Inc | 21130-784 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Family Dollar Stores, Inc. | 55319-917 |
| Fexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Walgreens Company | 0363-0783 |
| Fexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | KROGER COMPANY | 30142-878 |
| Fexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 43598-809 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 43598-936 |
| Fexofenadine hydrochloride | Fexofenadine hydrochloride 30 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-782 |
| Fexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-784 |
| Fexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Dollar General | 55910-111 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Chain Drug Marketing Associate | 63868-025 |
| Fexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | BluePoint Laboratories | 68001-439 |
| Fexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | BluePoint Laboratories | 68001-440 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Chain Drug Consortium, LLC | 68016-995 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Sam's West Inc. | 68196-107 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS Health Corp. | 69842-052 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Strategic Sourcing Services, LLC | 70677-1009 |
| Non-Drowsy Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | TARGET CORPORATION | 11673-621 |
| Wal-Fexfexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walgreens Company | 0363-0784 |