Over-the-counter drug · ANDA
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride NDC 58602-703
Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-703-09 | 5860207030958602070309 | 12 BLISTER PACK in 1 CARTON (58602-703-09) / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 8, 2023 | |
| 58602-703-53 | 5860207035358602070353 | 12 BLISTER PACK in 1 CARTON (58602-703-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 8, 2023 | |
| 58602-703-75 | 5860207037558602070375 | 2 BLISTER PACK in 1 CARTON (58602-703-75) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 8, 2023 | |
| 58602-703-76 | 5860207037658602070376 | 4 BLISTER PACK in 1 CARTON (58602-703-76) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 8, 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)
- Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
- Generic name (nonproprietary)
- cetirizine hydrochloride and pseudoephedrine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 5 mg/1Pseudoephedrine hydrochloride — 120 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 212409
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-703_36996eb4-9195-4bfc-a687-fdb4ea05a860SPL ID 36996eb4-9195-4bfc-a687-fdb4ea05a860SPL set ID 26f2c3c1-a2f2-474a-950a-8cfe07f289faRxCUI 1014571UNII 64O047KTOA, 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
N458602070309followed by a unit qualifier and the quantityPackage 58602-0703-09. 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 nasal congestion 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 58602-703
- What is NDC 58602-703?
- 58602-703 is the product NDC for Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride, Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Aurohealth LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride.
- What is the active ingredient?
- Cetirizine 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 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride?
- 3 other product NDCs are listed under this name. See all Cetirizine 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 Cetirizine 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) |
|---|---|---|---|---|---|
| Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-313 | 29300-0313-2229300-0313-24 |
| Cetirizine hydrochloride and Pseudoephedrine hydrochloridecetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Padagis Israel Pharmaceuticals Ltd | 45802-147 | 45802-0147-5345802-0147-62 |
| Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 62756-915 | 62756-0915-6262756-0915-73 |