HydrALAZINE Hydrochloride NDC 64380-735

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-735Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0735Add 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
64380-735-06	64380073506	100 TABLET in 1 BOTTLE (64380-735-06)Marketed from Jun 30, 2013
64380-735-07	64380073507	500 TABLET in 1 BOTTLE (64380-735-07)Marketed from Jun 30, 2013
64380-735-08	64380073508	1000 TABLET in 1 BOTTLE (64380-735-08)Marketed from Jun 30, 2013

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: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200770
Marketing start: Jun 30, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 64380-735_198e8715-f4c9-4b66-9e8e-61edab911f51SPL ID 198e8715-f4c9-4b66-9e8e-61edab911f51SPL set ID b3d1786d-c3ff-42f1-a09f-37a9c9021e5aRxCUI 905199, 905222, 905225, 905395UNII FD171B778YUPC 0364380735069, 0364380734062, 0364380734086, 0364380736066
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

N464380073506 followed by a unit qualifier and the quantity

Package 64380-0735-06. 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 Feb 2, 2026.

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 200770

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

FDA NDC Directory listings under ANDA 200770
Product	Strength	Form · route	Labeler	Product NDC
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-2080
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Strides Pharma Science Limited	64380-733
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Strides Pharma Science Limited	64380-734
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 100 mg/1	TabletOral	Strides Pharma Science Limited	64380-736
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Proficient Rx LP	71205-072