What is NDC 63323-614?

63323-614 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 20 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hydralazine Hydrochloride?

144 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydralazine Hydrochloride NDC 63323-614

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-614Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0614Add 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
63323-614-16	6332306141663323061416	25 VIAL, SINGLE-USE in 1 TRAY (63323-614-16) / 1 mL in 1 VIAL, SINGLE-USE (63323-614-41)Marketed from Sep 5, 2001

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: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040388
Marketing start: Sep 5, 2001
Listing expires: Dec 31, 2027
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 63323-614_b6d5484e-2814-4fdb-932b-79d7f6ca4f82SPL ID b6d5484e-2814-4fdb-932b-79d7f6ca4f82
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

N463323061416 followed by a unit qualifier and the quantity

Package 63323-0614-16. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 63323-614

What is NDC 63323-614?: 63323-614 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 20 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydralazine Hydrochloride.
What is the active ingredient?: Hydralazine hydrochloride.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydralazine Hydrochloride?: 144 other product NDCs are listed under this name. See all Hydralazine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hydralazine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0287	55154-0287-00
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-2080	67046-2080-03
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Safecor Health, LLC	48433-046	48433-0046-20
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Safecor Health, LLC	48433-047	48433-0047-20
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Safecor Health, LLC	48433-048	48433-0048-20
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-1660	67046-1660-03
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Navinta LLC	68475-514	68475-0514-02
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Coupler LLC	67046-1609	67046-1609-03
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Baxter Healthcare Corporation	43066-041	43066-0041-25
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0186	55154-0186-00

All 145 Hydralazine Hydrochloride NDCs

Other NDCs under ANDA 040388

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

FDA NDC Directory listings under ANDA 040388
Product	Strength	Form · route	Labeler	Product NDC
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9787
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1376
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-9554
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-9587
hydrALAZINE Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-3659
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7145
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7268
hydrALAZINE Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	ProPharma Distribution	84549-614