Over-the-counter drug · ANDA
Childrens Fexofenadine Hydrochloride Allergy (Fexofenadine hydrochloride) NDC 51672-2141
Fexofenadine hydrochloride 30 mg/5mL · Suspension · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-2141-1 | 5167221410151672214101 | 1 BOTTLE in 1 CARTON (51672-2141-1) / 240 mL in 1 BOTTLEMarketed from Jan 24, 2024 | |
| 51672-2141-8 | 5167221410851672214108 | 1 BOTTLE in 1 CARTON (51672-2141-8) / 120 mL in 1 BOTTLEMarketed from Jan 24, 2024 |
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)
- Childrens Fexofenadine Hydrochloride AllergySuffix: Allergy
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 30 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208123
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51672-2141_58cbdd55-848f-51c5-e063-6294a90aaa53SPL ID 58cbdd55-848f-51c5-e063-6294a90aaa53SPL set ID b21bb11d-bf74-4ee7-9cfe-5b599a3c4775RxCUI 997491UNII 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
N451672214101followed by a unit qualifier and the quantityPackage 51672-2141-01. 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 itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 51672-2141
- What is NDC 51672-2141?
- 51672-2141 is the product NDC for Childrens Fexofenadine Hydrochloride Allergy, Fexofenadine hydrochloride 30 mg/5mL suspension, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Fexofenadine Hydrochloride Allergy (Fexofenadine hydrochloride).
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Fexofenadine Hydrochloride Allergy?
- 2 other product NDCs are listed under this name. See all Childrens Fexofenadine Hydrochloride Allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Fexofenadine Hydrochloride Allergy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Fexofenadine Hydrochloride Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Walgreens Company | 0363-2141 | 00363-2141-0100363-2141-08 |
| Childrens Fexofenadine Hydrochloride Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 79903-306 | 79903-0306-04 |
Other NDCs under ANDA 208123
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 |
|---|---|---|---|---|
| Childrens Fexofenadine Hydrochloride Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Walgreens Company | 0363-2141 |
| Childrens Fexofenadine Hydrochloride Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 79903-306 |