Prescription drug · ANDA
Hydroxyzine Hydrochloride NDC 0404-9877
Hydroxyzine dihydrochloride 50 mg/mL · Injection, Solution · Intramuscular · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9877-01 | 00404987701 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9877-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 17, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087408
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0404-9877_0c90956b-50b1-4f90-97b3-e2f831693504SPL ID 0c90956b-50b1-4f90-97b3-e2f831693504SPL set ID 7279ad5a-0a49-432d-8fa2-17e4c6ecbadcRxCUI 1794554UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400404987701followed by a unit qualifier and the quantityPackage 00404-9877-01. 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 087408
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 | Hydroxyzine dihydrochloride 50 mg/mL | Injection, SolutionIntramuscular | Henry Schein, Inc. | 0404-9878 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/mL | Injection, SolutionIntramuscular | American Regent, Inc. | 0517-4201 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/mL | Injection, SolutionIntramuscular | American Regent, Inc. | 0517-5601 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 50 mg/mL | Injection, SolutionIntramuscular | American Regent, Inc. | 0517-5602 |
| Hydroxyzine Hydrochloride | Hydroxyzine dihydrochloride 25 mg/mL | Injection, SolutionIntramuscular | HF Acquisition Co LLC, DBA HealthFirst | 51662-1649 |