Over-the-counter drug · ANDA
Fexofenadine Hydrochloride NDC 68196-107
Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · Sam's West Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68196-107Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68196-0107Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-107-15 | 6819601071568196010715 | 1 BOTTLE in 1 CARTON (68196-107-15) / 150 TABLET in 1 BOTTLEMarketed from May 9, 2017 | |
| 68196-107-50 | 6819601075068196010750 | 150 TABLET in 1 BOTTLE (68196-107-50)Marketed from Apr 1, 2023 |
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
- Route
- Oral
- Labeler
- Sam's West Inc.NDC labeler code 68196
- 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 68196-107_573483c1-14c7-7ff1-a6ee-2d01a988333aSPL ID 573483c1-14c7-7ff1-a6ee-2d01a988333aSPL set ID 1c1f43c4-7128-37c4-83fe-7eefac3fd477RxCUI 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
N468196010715followed by a unit qualifier and the quantityPackage 68196-0107-15. 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 68196-107
- What is NDC 68196-107?
- 68196-107 is the product NDC for Fexofenadine Hydrochloride, Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by Sam's West Inc.. It has 2 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?
- Sam's West Inc., NDC labeler code 68196. 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 60 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-783 |
| 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 | 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 |