Over-the-counter drug · ANDA
Cetirizine Hydrochloride (Hives Relief) (Cetirizine hydrochloride) NDC 58602-447
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Aurohealth LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58602-447Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58602-0447Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-447-09 | 5860204470958602044709 | 1 BOTTLE in 1 CARTON (58602-447-09) / 30 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 | |
| 58602-447-17 | 5860204471758602044717 | 1 BOTTLE in 1 CARTON (58602-447-17) / 45 TABLET in 1 BOTTLEMarketed from Aug 5, 2015 | |
| 58602-447-21 | 5860204472158602044721 | 10 BLISTER PACK in 1 CARTON (58602-447-21) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 5, 2015 | |
| 58602-447-41 | 5860204474158602044741 | 1000 TABLET in 1 BOTTLE (58602-447-41)Marketed from Aug 5, 2015 | |
| 58602-447-47 | 5860204474758602044747 | 75 TABLET in 1 PACKAGE, COMBINATION (58602-447-47)Marketed from Aug 5, 2015 |
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 (Hives Relief)
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090760
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-447_9e202d7d-9a96-448b-bd71-bd7234b9e2a2SPL ID 9e202d7d-9a96-448b-bd71-bd7234b9e2a2SPL set ID 2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0aRxCUI 1014676, 1014678UNII 64O047KTOA
- 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
N458602044709followed by a unit qualifier and the quantityPackage 58602-0447-09. 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 reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Excerpt only. Read the full label for complete information.
About NDC 58602-447
- What is NDC 58602-447?
- 58602-447 is the product NDC for Cetirizine Hydrochloride (Hives Relief), Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Aurohealth LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride (Hives Relief) (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine 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 (Hives Relief)?
- 4 other product NDCs are listed under this name. See all Cetirizine Hydrochloride (Hives Relief) 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 (Hives Relief) 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 (Hives Relief)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Aurohealth LLC | 58602-808 | 58602-0808-0458602-0808-1258602-0808-16+1 more |
| Cetirizine Hydrochloride (Hives Relief)cetirizine hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | Aurohealth LLC | 58602-446 | 58602-0446-0958602-0446-1758602-0446-21+2 more |
| Cetirizine Hydrochloride (Hives Relief)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-813 | 58602-0813-0458602-0813-0958602-0813-17+5 more |
| Cetirizine Hydrochloride Hives Reliefcetirizine | Cetirizine hydrochloride 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-145 | 65162-0145-0365162-0145-50 |
Other NDCs under ANDA 090760
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 |
|---|---|---|---|---|
| Amazon Basic Care All Day Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Amazon.com Services LLC | 72288-691 |
| Cetirizine Hydrochloridecetirizine hydrochloride allergy | Cetirizine hydrochloride 10 mg/1 | TabletOral | LEADER/ CARDINAL HEALTH 110, INC. | 70000-0047 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | WALGREEN CO. | 0363-9602 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | NorthStar Rx LLC | 16714-799 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Better Living Brands, LLC | 21130-098 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | KROGER COMPANY | 30142-172 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6168 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6170 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6950 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | INNOVUS PHARMACEUTICALS, INC. | 57483-190 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | Aurohealth LLC | 58602-444 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-445 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-812 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-823 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aurohealth LLC | 58602-861 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | BluePoint Laboratories | 68001-436 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8204 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS Pharmacy, Inc. | 69842-237 |
| Cetirizine Hydrochloride (Allergy)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-700 |
| Cetirizine Hydrochloride (Hives Relief)cetirizine hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | Aurohealth LLC | 58602-446 |
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