What is NDC 82804-081?

82804-081 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 25 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 82804. 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 82804-081

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0081Add 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
82804-081-30	8280400813082804008130	30 TABLET in 1 BOTTLE (82804-081-30)Marketed from Mar 7, 2024
82804-081-60	8280400816082804008160	60 TABLET in 1 BOTTLE (82804-081-60)Marketed from Mar 7, 2024
82804-081-72	8280400817282804008172	120 TABLET in 1 BOTTLE (82804-081-72)Marketed from Jul 18, 2025
82804-081-90	8280400819082804008190	90 TABLET in 1 BOTTLE (82804-081-90)Marketed from Mar 7, 2024

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 — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040858
Marketing start: Aug 2, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 82804-081_004f0059-4ede-4748-9489-45e27c177424SPL ID 004f0059-4ede-4748-9489-45e27c177424SPL set ID 024ac6b8-5ce0-4435-9b11-b1806c511d7bRxCUI 905225UNII FD171B778YUPC 0382804081301
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

N482804008130 followed by a unit qualifier and the quantity

Package 82804-0081-30. 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 Jul 1, 2025.

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)

About NDC 82804-081

What is NDC 82804-081?: 82804-081 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 25 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, 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?: Proficient Rx LP, NDC labeler code 82804. 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 040858

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

FDA NDC Directory listings under ANDA 040858
Product	Strength	Form · route	Labeler	Product NDC
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7447
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Major Pharmaceuticals	0904-7448
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Major Pharmaceuticals	0904-7449
Hydralazine Hydrochloride	Hydralazine hydrochloride 100 mg/1	TabletOral	Major Pharmaceuticals	0904-7450
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-832
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-833
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-834
Hydralazine Hydrochloride	Hydralazine hydrochloride 100 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-835
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0186
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0187
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2140
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2141
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	American Health Packaging	60687-811
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	American Health Packaging	60687-822
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	American Health Packaging	60687-833
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Coupler LLC	67046-1520
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4007
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4022
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-4064
Hydralazine Hydrochloride	Hydralazine hydrochloride 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-4352

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