Prescription drug · ANDA
Hydralazine Hydrochloride NDC 67544-657
Hydralazine hydrochloride 25 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67544-657-60 | 67544065760 | 90 TABLET in 1 BOTTLE (67544-657-60)Marketed from Jun 21, 2010 | |
| 67544-657-80 | 67544065780 | 180 TABLET in 1 BOTTLE (67544-657-80)Marketed from Dec 7, 2015 | |
| 67544-657-92 | 67544065792 | 270 TABLET in 1 BOTTLE (67544-657-92)Marketed from Nov 17, 2015 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088467
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 67544-657_b08e0b2c-c3c7-42f4-a43c-5eb32ce5be79SPL ID b08e0b2c-c3c7-42f4-a43c-5eb32ce5be79SPL set ID bfbd5960-ae6b-46f5-adfa-e330d7a21dfaRxCUI 905225UNII 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 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
N467544065760followed by a unit qualifier and the quantityPackage 67544-0657-60. 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 088467
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 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8757 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1521 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5689 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-075 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Safecor Health, LLC | 48433-047 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 50111-327 |