Prescription drug · ANDA
Hydroxyzine Hydrochloride (Hydroxyzine hydrochloride oral) NDC 69452-395
Hydroxyzine dihydrochloride 10 mg/5mL · Solution · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-395-88 | 6945203958869452039588 | 473 mL in 1 BOTTLE (69452-395-88)Marketed from Jul 17, 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 oral
- Active ingredients
- Hydroxyzine dihydrochloride — 10 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219289
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69452-395_39f93640-6535-6c3b-e063-6394a90a7f2dSPL ID 39f93640-6535-6c3b-e063-6394a90a7f2dSPL set ID 39f93633-000e-6c3f-e063-6394a90a5a0bRxCUI 995241UNII 76755771U3UPC 0369452395882
- 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
N469452039588followed by a unit qualifier and the quantityPackage 69452-0395-88. 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 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 in …
Excerpt only. Read the full label for complete information.
About NDC 69452-395
- What is NDC 69452-395?
- 69452-395 is the product NDC for Hydroxyzine Hydrochloride (hydroxyzine hydrochloride oral), Hydroxyzine dihydrochloride 10 mg/5mL solution, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride Oral).
- What is the active ingredient?
- Hydroxyzine dihydrochloride.
- Who is the labeler?
- Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydroxyzine Hydrochloride?
- 194 other product NDCs are listed under this name. See all Hydroxyzine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydroxyzine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 10 mg/5mL | SolutionOral | Advagen Pharma Limited | 72888-218 | 72888-0218-13 |
| Hydroxyzine hydrochloride | Hydroxyzine hydrochloride 50 mg/1 | TabletOral | Coupler LLC | 67046-0566 | 67046-0566-03 |
| Hydroxyzine hydrochloride | Hydroxyzine hydrochloride 10 mg/1 | TabletOral | Coupler LLC | 67046-0833 | 67046-0833-03 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0590 | 80425-0590-0180425-0590-0280425-0590-03 |
| Hydroxyzine hydrochloride | Hydroxyzine hydrochloride 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-039 | 87441-0039-01 |
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 10 mg/5mL | SolutionOral | Saptalis Pharmaceuticals, LLC. | 71656-090 | 71656-0090-16 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1311 | 67046-1311-03 |
| Hydroxyzine hydrochloride | Hydroxyzine dihydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-0713 | 67046-0713-03 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 10 mg/5mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-912 | 70954-0912-10 |
| Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2148 | 55154-2148-00 |
Other NDCs under ANDA 219289
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/5mL | SolutionOral | Kesin Pharma | 81033-031 |