Prescription drug · ANDA
Hydralazine Hydrochloride NDC 55154-5085
Hydralazine hydrochloride 50 mg/1 · Tablet · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-5085-0 | 55154508500 | 10 BLISTER PACK in 1 BAG (55154-5085-0) / 1 TABLET in 1 BLISTER PACKMarketed from May 13, 2011 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088468
- Marketing start
- Marketing end
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 55154-5085_0489db42-3dc0-4415-a2a6-ea6833c93590SPL ID 0489db42-3dc0-4415-a2a6-ea6833c93590SPL set ID db7500f3-f8a6-46b1-bb64-9727617a9643RxCUI 905225, 905395UNII FD171B778YUPC 0055154508506, 0055154568906
- 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 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
N455154508500followed by a unit qualifier and the quantityPackage 55154-5085-00. 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 Essential hypertension, alone or as an adjunct.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 088468
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 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0287 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-076 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Safecor Health, LLC | 48433-048 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6608 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 50111-328 |