Over-the-counter drug · ANDA
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride NDC 58602-844
Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1 · Tablet, Film coated, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-844-60 | 5860208446058602084460 | 1 BLISTER PACK in 1 CARTON (58602-844-60) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 17, 2025 | |
| 58602-844-66 | 5860208446658602084466 | 2 BLISTER PACK in 1 CARTON (58602-844-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 17, 2025 | |
| 58602-844-85 | 5860208448558602084485 | 3 BLISTER PACK in 1 CARTON (58602-844-85) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 17, 2025 |
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 and Pseudoephedrine Hydrochloride
- Generic name (nonproprietary)
- fexofenadine hydrochloride and pseudoephedrine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1Pseudoephedrine hydrochloride — 240 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215232
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-844_bced0a2e-047e-456e-bbd2-495e83bf07eeSPL ID bced0a2e-047e-456e-bbd2-495e83bf07eeSPL set ID bced0a2e-047e-456e-bbd2-495e83bf07eeRxCUI 997415UNII 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
N458602084460followed by a unit qualifier and the quantityPackage 58602-0844-60. 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 58602-844
- What is NDC 58602-844?
- 58602-844 is the product NDC for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride, Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1 tablet, film coated, extended release, listed with the FDA by Aurohealth LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride.
- What is the active ingredient?
- Fexofenadine hydrochloride, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. 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 and Pseudoephedrine Hydrochloride?
- 21 other product NDCs are listed under this name. See all Fexofenadine Hydrochloride and Pseudoephedrine 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 and Pseudoephedrine 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 Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1 | Tablet, Film coated, Extended releaseOral | WALGREEN CO. | 0363-0270 | 00363-0270-10 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Rugby Laboratories | 0536-1431 | 00536-1431-0700536-1431-34 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health | 70000-0677 | 70000-0677-0170000-0677-02 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy, Inc. | 51316-007 | 51316-0007-6751316-0007-84 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | CVS Health Corp | 51316-015 | 51316-0015-2051316-0015-30 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Walgreens Company | 0363-0044 | 00363-0044-2000363-0044-30 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-0021 | 11822-0021-0411822-0021-06 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-097 | 30142-0097-20 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1010 | 70677-1010-01 |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Wal-mart Stores, Inc. | 79903-108 | 79903-0108-2079903-0108-30 |
All 22 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride NDCs
Other NDCs under ANDA 215232
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 and Pseudoephedrine Hydrochloride | Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1 | Tablet, Film coated, Extended releaseOral | WALGREEN CO. | 0363-0270 |