Prescription drug · ANDA
Hydralazine Hydrochloride NDC 68071-2055
Hydralazine hydrochloride 10 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2055-3 | 68071205503 | 30 TABLET in 1 BOTTLE (68071-2055-3)Marketed from Jan 1, 2010 | |
| 68071-2055-6 | 68071205506 | 60 TABLET in 1 BOTTLE (68071-2055-6)Marketed from Jan 1, 2010 | |
| 68071-2055-9 | 68071205509 | 90 TABLET in 1 BOTTLE (68071-2055-9)Marketed from Jan 1, 2010 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040901
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 68071-2055_1d609c11-a29c-eb81-e063-6294a90a7472SPL ID 1d609c11-a29c-eb81-e063-6294a90a7472SPL set ID 3b61d1b0-c699-67a8-e054-00144ff88e88RxCUI 905199UNII FD171B778YUPC 0368071205534
- 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
N468071205503followed by a unit qualifier and the quantityPackage 68071-2055-03. 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 040901
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 | 71335-0202 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-1940 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8087 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7973 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-520 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-519 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-521 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-522 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Proficient Rx LP | 82804-197 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-091 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6684 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5246 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5285 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1589 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2551 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-0137 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-0139 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1685 |