Prescription drug · ANDA
Hydroxyzine Hydrochloride NDC 16571-114
Hydroxyzine dihydrochloride 25 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-114-01 | 16571011401 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-114-01)Marketed from Aug 22, 2023 | |
| 16571-114-10 | 16571011410 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-114-10)Marketed from Aug 22, 2023 | |
| 16571-114-50 | 16571011450 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-114-50)Marketed from Aug 22, 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)
- Hydroxyzine Hydrochloride
- Generic name (nonproprietary)
- hydroxyzine hydrochloride
- Active ingredients
- Hydroxyzine dihydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217652
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 16571-114_20aba551-c0c0-4ea1-8200-ad81956ff294SPL ID 20aba551-c0c0-4ea1-8200-ad81956ff294SPL set ID 6a1a48ac-8ad5-4363-b298-d9825ae2a448RxCUI 995218, 995258, 995281UNII 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
N416571011401followed by a unit qualifier and the quantityPackage 16571-0114-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217652
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 hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2636 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-113 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-115 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2410 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8872 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc | 68071-3964 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-5291 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-5296 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0590 |
| Hydroxyzine HCL | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Direct_rx | 72189-577 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-288 |
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8707 |
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4141 |
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 25 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-990 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0394 |
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3061 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4170 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1311 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7329 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7327 |
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