Over-the-counter drug · NDA
Allegra-D NDC 50090-1203
fexofenadine hydrochloride and pseudoephedrine hydrochloride · Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1203-0 | 50090120300 | 1 BLISTER PACK in 1 CARTON (50090-1203-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 28, 2014 |
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)
- Allegra-D
- Generic name (nonproprietary)
- fexofenadine hydrochloride and pseudoephedrine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020786
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-1203_a0388348-fc41-4d13-81ad-d8f25cd154d9SPL ID a0388348-fc41-4d13-81ad-d8f25cd154d9SPL set ID 705e1087-61cb-43c3-8675-f56626a1707bRxCUI 997406, 997512UNII 2S068B75ZU, 6V9V2RYJ8N
- Pharmacologic class
- Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist
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
N450090120300followed by a unit qualifier and the quantityPackage 50090-1203-00. 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 temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose
Excerpt only. Read the full label for complete information.
About NDC 50090-1203
- What is NDC 50090-1203?
- 50090-1203 is the product NDC for Allegra-D, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allegra-D (Fexofenadine hydrochloride and pseudoephedrine hydrochloride).
- What is the active ingredient?
- Fexofenadine hydrochloride, Pseudoephedrine hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allegra-D?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 020786
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 |
|---|---|---|---|---|
| Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Chattem, Inc. | 41167-4310 |