Prescription drug · ANDA

Hydralazine Hydrochloride NDC 67046-1520

Hydralazine hydrochloride 10 mg/1 · Tablet · Oral · Coupler LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1520Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1520Add 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 NDC11-digit (billing)PackageCopy
67046-1520-3670461520036704615200330 TABLET in 1 BLISTER PACK (67046-1520-3)Marketed from Feb 20, 2025

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 — 10 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 040858
Marketing start
Listing expires
Other FDA classes
Arteriolar Vasodilation (Physiologic effect)
Identifiers
Product ID 67046-1520_2e96a363-6799-774a-e063-6394a90aac75SPL ID 2e96a363-6799-774a-e063-6394a90aac75SPL set ID 2e9688ef-781c-aead-e063-6294a90a7bcaRxCUI 905199UNII 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

N467046152003 followed by a unit qualifier and the quantity

Package 67046-1520-03. 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

Current FDA label (SPL), effective .

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 67046-1520

What is NDC 67046-1520?
67046-1520 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 10 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralCardinal Health 107, LLC55154-028755154-0287-00
HydrALAZINE HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralCoupler LLC67046-208067046-2080-03
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralSafecor Health, LLC48433-04648433-0046-20
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralSafecor Health, LLC48433-04748433-0047-20
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralSafecor Health, LLC48433-04848433-0048-20
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralCoupler LLC67046-166067046-1660-03
Hydralazine HydrochlorideHydralazine hydrochloride 20 mg/mLInjectionIntramuscular, IntravenousNavinta LLC68475-51468475-0514-02
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralCoupler LLC67046-160967046-1609-03
Hydralazine HydrochlorideHydralazine hydrochloride 20 mg/mLInjectionIntramuscular, IntravenousBaxter Healthcare Corporation43066-04143066-0041-25
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralCardinal Health 107, LLC55154-018655154-0186-00

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
ProductStrengthForm · routeLabelerProduct NDC
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralMajor Pharmaceuticals0904-7447
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralMajor Pharmaceuticals0904-7448
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralMajor Pharmaceuticals0904-7449
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralMajor Pharmaceuticals0904-7450
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-832
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-833
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-834
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-835
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralCardinal Health 107, LLC55154-0186
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralCardinal Health 107, LLC55154-0187
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralCardinal Health 107, LLC55154-2140
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralCardinal Health 107, LLC55154-2141
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralAmerican Health Packaging60687-811
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralAmerican Health Packaging60687-822
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralAmerican Health Packaging60687-833
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralREMEDYREPACK INC.70518-4007
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralREMEDYREPACK INC.70518-4022
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-4064
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralREMEDYREPACK INC.70518-4352
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralProficient Rx LP82804-081

Showing 20 of 21.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in