Prescription drug · ANDA
Hydralazine Hydrochloride NDC 55154-9587
Hydralazine hydrochloride 20 mg/mL · Injection · Intramuscular, Intravenous · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-9587-5 | 55154958705 | 5 VIAL, SINGLE-USE in 1 BAG (55154-9587-5) / 1 mL in 1 VIAL, SINGLE-USEMarketed from Oct 31, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Hydralazine Hydrochloride
- Generic name (nonproprietary)
- hydralazine hydrochloride
- Active ingredients
- Hydralazine hydrochloride — 20 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040388
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 55154-9587_b00ee56d-44d3-4fc6-8004-52e1e6f21451SPL ID b00ee56d-44d3-4fc6-8004-52e1e6f21451SPL set ID 8b7e88ef-5edd-40df-8e43-e3f29970be58RxCUI 966571UNII FD171B778YUPC 0055154958752
- Pharmacologic class
- Arteriolar Vasodilator
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
N455154958705followed by a unit qualifier and the quantityPackage 55154-9587-05. 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: Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040388
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 |
|---|---|---|---|---|
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9787 |
| hydrALAZINE Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-3659 |
| hydrALAZINE Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-614 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7145 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-614 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-614 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-614 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-9554 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7268 |
| hydrALAZINE Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | ProPharma Distribution | 84549-614 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1376 |