Prescription drug · ANDA
Hydralazine Hydrochloride NDC 68462-343
Hydralazine hydrochloride 50 mg/1 · Tablet · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-343-01 | 68462034301 | 100 TABLET in 1 BOTTLE (68462-343-01)Marketed from May 29, 2009 | |
| 68462-343-05 | 68462034305 | 500 TABLET in 1 BOTTLE (68462-343-05)Marketed from May 29, 2009 | |
| 68462-343-10 | 68462034310 | 1000 TABLET in 1 BOTTLE (68462-343-10)Marketed from May 29, 2009 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090527
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 68462-343_617acbb5-012a-416f-bf6c-fd766a25711cSPL ID 617acbb5-012a-416f-bf6c-fd766a25711cSPL set ID 37ba0233-ed75-498a-a067-6220da573653RxCUI 905199, 905222, 905225, 905395UNII FD171B778YUPC 0368462343012, 0368462342015, 0368462344019, 0368462341018
- 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
N468462034301followed by a unit qualifier and the quantityPackage 68462-0343-01. 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 090527
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 | Glenmark Pharmaceuticals Inc., USA | 68462-342 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 10 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-341 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 100 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-344 |