What is NDC 67046-2080?

67046-2080 is the product NDC for HydrALAZINE Hydrochloride, Hydralazine hydrochloride 50 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. 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 67046-2080

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-2080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-2080Add 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
67046-2080-3	6704620800367046208003	30 TABLET in 1 BLISTER PACK (67046-2080-3)Marketed from Aug 7, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200770
Marketing start: Aug 7, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 67046-2080_58773dbd-7c36-7daa-e063-6394a90a6666SPL ID 58773dbd-7c36-7daa-e063-6394a90a6666SPL set ID 58773e8c-b6bc-6bc6-e063-6294a90adc26RxCUI 905395UNII 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

N467046208003 followed by a unit qualifier and the quantity

Package 67046-2080-03. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 67046-2080

What is NDC 67046-2080?: 67046-2080 is the product NDC for HydrALAZINE Hydrochloride, Hydralazine hydrochloride 50 mg/1 tablet, listed with the FDA by Coupler 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?: Coupler LLC, NDC labeler code 67046. 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 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
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0187	55154-0187-00

All 145 HydrALAZINE Hydrochloride NDCs

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 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 50 mg/1	TabletOral	Strides Pharma Science Limited	64380-735
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