Prescription drug · ANDA
HydrALAZINE Hydrochloride NDC 67046-2080
Hydralazine hydrochloride 50 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-2080-3 | 67046208003 | 30 TABLET in 1 BLISTER PACK (67046-2080-3)Marketed from Aug 7, 2026 |
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
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200770
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 67046-2080_58773dbd-7c36-7daa-e063-6394a90a6666SPL ID 58773dbd-7c36-7daa-e063-6394a90a6666SPL set ID 58773e8c-b6bc-6bc6-e063-6294a90adc26RxCUI 905395UNII 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
N467046208003followed by a unit qualifier and the quantityPackage 67046-2080-03. 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 200770
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 | Strides Pharma Science Limited | 64380-735 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-733 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-734 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-736 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Proficient Rx LP | 71205-072 |