Hydralazine Hydrochloride NDC 43353-124

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-124Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0124Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43353-124-05	43353012405	4200 TABLET in 1 BOTTLE (43353-124-05)Marketed from Dec 2, 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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089098
Marketing start: Sep 30, 1990
Listing expires: Dec 31, 2026
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 43353-124_66435209-390b-4344-9b5b-47c9c2d92e2fSPL ID 66435209-390b-4344-9b5b-47c9c2d92e2fSPL set ID d9892176-d4a6-4edb-92b9-5f56243f3d22RxCUI 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

N443353012405 followed by a unit qualifier and the quantity

Package 43353-0124-05. 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 Jun 13, 2016.

Indications (excerpt from the label)

INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 089098

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 089098
Product	Strength	Form · route	Labeler	Product NDC
Hydralazine Hydrochloride	Hydralazine hydrochloride 100 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	50111-397