Hydralazine Hydrochloride NDC 68475-514

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-514Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0514Add 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
68475-514-02	68475051402	25 VIAL in 1 PACKAGE (68475-514-02) / 1 mL in 1 VIAL (68475-514-01)Marketed from Nov 25, 2025

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 — 20 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Navinta LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202938
Marketing start: Nov 25, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 68475-514_e9ca27ef-fa6d-4b88-a84b-9a56bffe2020SPL ID e9ca27ef-fa6d-4b88-a84b-9a56bffe2020SPL set ID ae5d85df-11a3-4952-ade2-596d57cdd987RxCUI 966571UNII FD171B778YUPC 0368475514010
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468475051402 followed by a unit qualifier and the quantity

Package 68475-0514-02. 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 Apr 21, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202938

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

FDA NDC Directory listings under ANDA 202938
Product	Strength	Form · route	Labeler	Product NDC
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Zydus Pharmaceuticals USA Inc.	70710-1988