Prescription drug · ANDA
Hydralazine Hydrochloride NDC 72241-005
Hydralazine hydrochloride 50 mg/1 · Tablet · Oral · Modavar Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72241-005-05 | 72241000505 | 100 TABLET in 1 BOTTLE (72241-005-05)Marketed from Dec 29, 2015 | |
| 72241-005-11 | 72241000511 | 1000 TABLET in 1 BOTTLE (72241-005-11)Marketed from Dec 29, 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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Modavar Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203845
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 72241-005_2be4a232-7aa2-44f8-ba8c-f5b64677c1b7SPL ID 2be4a232-7aa2-44f8-ba8c-f5b64677c1b7SPL set ID a456bc34-0c79-44f4-9119-50028a978f5fRxCUI 905222, 905225, 905395UNII FD171B778YUPC 0372241006111
- 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
N472241000505followed by a unit qualifier and the quantityPackage 72241-0005-05. 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)
INDICATIONS & USAGE Essential hypertension, alone or as an adjunct.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203845
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 | Coupler LLC | 67046-1517 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-016 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-017 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-018 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 25 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-004 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-006 |