Prescription drug · ANDA
Hydralazine Hydrochloride NDC 55150-400
Hydralazine hydrochloride 20 mg/mL · Injection · Intramuscular, Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-400-25 | 5515004002555150040025 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-400-25) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 13, 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)
- Hydralazine Hydrochloride
- Generic name (nonproprietary)
- hydralazine hydrochloride
- Active ingredients
- Hydralazine hydrochloride — 20 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215147
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 55150-400_f725ae73-cab2-4a30-901c-9f8856803f3aSPL ID f725ae73-cab2-4a30-901c-9f8856803f3aSPL set ID e08d8b6c-a184-4dd5-84ef-bac90e4b1c33RxCUI 966571UNII FD171B778Y
- 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
N455150040025followed by a unit qualifier and the quantityPackage 55150-0400-25. 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.
About NDC 55150-400
- What is NDC 55150-400?
- 55150-400 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 20 mg/mL injection, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydralazine Hydrochloride.
- What is the active ingredient?
- Hydralazine hydrochloride.
- Who is the labeler?
- Eugia US LLC, NDC labeler code 55150. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydralazine Hydrochloride?
- 144 other product NDCs are listed under this name. See all Hydralazine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydralazine 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) |
|---|---|---|---|---|---|
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0287 | 55154-0287-00 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Coupler LLC | 67046-2080 | 67046-2080-03 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Safecor Health, LLC | 48433-046 | 48433-0046-20 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Safecor Health, LLC | 48433-047 | 48433-0047-20 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Safecor Health, LLC | 48433-048 | 48433-0048-20 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-1660 | 67046-1660-03 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Navinta LLC | 68475-514 | 68475-0514-02 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Coupler LLC | 67046-1609 | 67046-1609-03 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 20 mg/mL | InjectionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-041 | 43066-0041-25 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0186 | 55154-0186-00 |
Other NDCs under ANDA 215147
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 | Medical Purchasing Solutions, LLC | 71872-7339 |