Prescription drug · ANDA
Hydroxyzine Hydrochloride NDC 10702-011
Hydroxyzine dihydrochloride 25 mg/1 · Tablet, Film coated · Oral · KVK-Tech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-011-01 | 10702001101 | 100 TABLET, FILM COATED in 1 BOTTLE (10702-011-01)Marketed from Jul 24, 2012 | |
| 10702-011-10 | 10702001110 | 1000 TABLET, FILM COATED in 1 BOTTLE (10702-011-10)Marketed from Jul 24, 2012 | |
| 10702-011-50 | 10702001150 | 500 TABLET, FILM COATED in 1 BOTTLE (10702-011-50)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
- KVK-Tech, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040786
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 10702-011_eff46bea-a884-5878-e053-2a95a90ae664SPL ID eff46bea-a884-5878-e053-2a95a90ae664SPL set ID adc4cb73-77c6-48ff-aaf2-b3568d53de1fRxCUI 995218, 995258, 995281UNII 76755771U3UPC 0310702012103
- 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
N410702001101followed by a unit qualifier and the quantityPackage 10702-0011-01. 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 040786
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 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-943 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-960 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2451 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | Tablet, Film coatedOral | KVK-Tech, Inc. | 10702-010 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-627 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | KVK-Tech, Inc. | 10702-012 |