Prescription drug · ANDA
Hydralazine Hydrochloride NDC 63629-8757
Hydralazine hydrochloride 25 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8757-1 | 63629875701 | 1000 TABLET in 1 BOTTLE (63629-8757-1)Marketed from Aug 20, 2021 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 63629-8757_3335c836-5e3d-4b72-b9d1-b3365cbe28b6SPL ID 3335c836-5e3d-4b72-b9d1-b3365cbe28b6SPL set ID 10f3e76e-9bba-4151-89fb-90d823a0a68cRxCUI 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
N463629875701followed by a unit qualifier and the quantityPackage 63629-8757-01. 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
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 | Aphena Pharma Solutions - Tennessee, LLC | 67544-657 |
| 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 |