Over-the-counter drug · ANDA
Cetirizine Hydrochloride Hives Relief (Cetirizine) NDC 65162-145
Cetirizine hydrochloride 5 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-145-03 | 6516201450365162014503 | 1 BOTTLE in 1 CARTON (65162-145-03) / 30 TABLET in 1 BOTTLEMarketed from Jan 21, 2010 | |
| 65162-145-50 | 6516201455065162014550 | 500 TABLET in 1 BOTTLE (65162-145-50)Marketed from Jan 21, 2010 |
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 ReliefSuffix: Hives Relief
- Generic name (nonproprietary)
- cetirizine
- Active ingredients
- Cetirizine hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078780
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65162-145_2231625e-ba4f-4106-81ed-12137d0464a6SPL ID 2231625e-ba4f-4106-81ed-12137d0464a6SPL set ID aad39214-5bf1-427b-a00e-410224c51c95RxCUI 1014676UNII 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
N465162014503followed by a unit qualifier and the quantityPackage 65162-0145-03. 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)
INDICATIONS AND USAGE 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 65162-145
- What is NDC 65162-145?
- 65162-145 is the product NDC for Cetirizine Hydrochloride Hives Relief, Cetirizine hydrochloride 5 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride Hives Relief (Cetirizine).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 | 58602-447 | 58602-0447-0958602-0447-1758602-0447-21+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 |
Other NDCs under ANDA 078780
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 |
|---|---|---|---|---|
| Allergy Relief All Daycetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-129 |
| Cetirizine Hydrochloridecetirizine | Cetirizine hydrochloride 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-045 |
| Cetirizine Hydrochloridecetirizine | Cetirizine hydrochloride 10 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-046 |