Prescription drug · ANDA
Hydroxyzine Hydrochloride NDC 43063-518
Hydroxyzine dihydrochloride 25 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-518-06 | 43063051806 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-06)Marketed from Jul 24, 2012 | |
| 43063-518-12 | 43063051812 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-12)Marketed from Jul 24, 2012 | |
| 43063-518-20 | 43063051820 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-20)Marketed from Jul 24, 2012 | |
| 43063-518-28 | 43063051828 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-28)Marketed from Jul 24, 2012 | |
| 43063-518-30 | 43063051830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-30)Marketed from Jul 24, 2012 | |
| 43063-518-40 | 43063051840 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-40)Marketed from Jul 24, 2012 | |
| 43063-518-60 | 43063051860 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-60)Marketed from Dec 18, 2019 | |
| 43063-518-90 | 43063051890 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-90)Marketed from Jul 24, 2012 |
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)
- Hydroxyzine Hydrochloride
- Generic name (nonproprietary)
- hydroxyzine hydrochloride
- Active ingredients
- Hydroxyzine dihydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040787
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43063-518_4138e4f8-23cf-c563-e063-6294a90ad9bbSPL ID 4138e4f8-23cf-c563-e063-6294a90ad9bbSPL set ID 24cb9c83-a7e4-4bae-997c-c3a87426f78cRxCUI 995258UNII 76755771U3
- Pharmacologic class
- Antihistamine
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
N443063051806followed by a unit qualifier and the quantityPackage 43063-0518-06. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 040787
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 |
|---|---|---|---|---|
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1730 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-962 |