What is NDC 76282-312?

76282-312 is the product NDC for HydrALAZINE Hydrochloride, Hydralazine hydrochloride 100 mg/1 tablet, listed with the FDA by Exelan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Exelan Pharmaceuticals Inc., NDC labeler code 76282. 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 76282-312

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0312Add 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
76282-312-01	7628203120176282031201	100 TABLET in 1 BOTTLE (76282-312-01)Marketed from May 20, 2016

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Exelan Pharmaceuticals Inc.NDC labeler code 76282
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090255
Marketing start: May 20, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 76282-312_f313fc00-1f7a-40ea-9d61-29c4bfba2426SPL ID f313fc00-1f7a-40ea-9d61-29c4bfba2426SPL set ID 811831f9-a844-463a-874d-fb8407659f0bRxCUI 905199, 905222, 905225, 905395UNII FD171B778YUPC 0376282309019, 0376282310015, 0376282311012, 0376282312019
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

N476282031201 followed by a unit qualifier and the quantity

Package 76282-0312-01. 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 Sep 4, 2020.

Indications (excerpt from the label)

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 76282-312

What is NDC 76282-312?: 76282-312 is the product NDC for HydrALAZINE Hydrochloride, Hydralazine hydrochloride 100 mg/1 tablet, listed with the FDA by Exelan Pharmaceuticals Inc.. 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?: Exelan Pharmaceuticals Inc., NDC labeler code 76282. 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 090255

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

FDA NDC Directory listings under ANDA 090255
Product	Strength	Form · route	Labeler	Product NDC
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 100 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-205
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Exelan Pharmaceuticals Inc.	76282-309
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Exelan Pharmaceuticals Inc.	76282-310
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Exelan Pharmaceuticals Inc.	76282-311