Prescription drug · ANDA
HydrALAZINE Hydrochloride NDC 43353-205
Hydralazine hydrochloride 100 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-205-05 | 43353020505 | 4200 TABLET in 1 BOTTLE (43353-205-05)Marketed from Jul 9, 2016 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090255
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 43353-205_7ff2351c-0271-49c1-b5d4-cb73b76a508cSPL ID 7ff2351c-0271-49c1-b5d4-cb73b76a508cSPL set ID 921c8693-84c2-4313-a2a6-ab3be637d554RxCUI 905222UNII 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
N443353020505followed by a unit qualifier and the quantityPackage 43353-0205-05. 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)
Essential hypertension, alone or as an adjunct.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090255
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 10 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-309 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-310 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-311 |
| HydrALAZINE Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-312 |