Prescription drug · ANDA
Hydroxyzine Hydrochloride NDC 10135-812
Hydroxyzine dihydrochloride 50 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-812-01 | 10135081201 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-812-01)Marketed from Mar 1, 2025 | |
| 10135-812-10 | 10135081210 | 1000 TABLET, FILM COATED in 1 BOTTLE (10135-812-10)Marketed from Mar 1, 2025 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207121
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 10135-812_31a907fc-2be0-1219-e063-6294a90ac00fSPL ID 31a907fc-2be0-1219-e063-6294a90ac00fSPL set ID 31a907e6-7fae-0682-e063-6294a90a24a5RxCUI 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
N410135081201followed by a unit qualifier and the quantityPackage 10135-0812-01. 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 207121
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 | Marlex Pharmaceuticals, Inc. | 10135-810 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-811 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/1 | Tablet, Film coatedOral | Sunrise Pharmaceutical, Inc. | 11534-204 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Sunrise Pharmaceutical, Inc. | 11534-205 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/1 | Tablet, Film coatedOral | Sunrise Pharmaceutical, Inc. | 11534-206 |