NDC codes

FDA NDC Directory
Product NDC (as listed)55154-5689Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-5689Add 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
55154-5689-0551545689005515456890010 BLISTER PACK in 1 BAG (55154-5689-0) / 1 TABLET in 1 BLISTER PACKMarketed from May 13, 2011

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 — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Cardinal Health 107, LLCNDC labeler code 55154
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 088467
Marketing start
Listing expires
Other FDA classes
Arteriolar Vasodilation (Physiologic effect)
Identifiers
Product ID 55154-5689_0489db42-3dc0-4415-a2a6-ea6833c93590SPL ID 0489db42-3dc0-4415-a2a6-ea6833c93590SPL set ID db7500f3-f8a6-46b1-bb64-9727617a9643RxCUI 905225, 905395UNII FD171B778YUPC 0055154508506, 0055154568906
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

N455154568900 followed by a unit qualifier and the quantity

Package 55154-5689-00. 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 55154-5689

What is NDC 55154-5689?
55154-5689 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 25 mg/1 tablet, listed with the FDA by Cardinal Health 107, 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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 088467

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

FDA NDC Directory listings under ANDA 088467
ProductStrengthForm · routeLabelerProduct NDC
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralSafecor Health, LLC48433-047
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralTeva Pharmaceuticals USA, Inc.50111-327
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralMylan Institutional Inc.51079-075
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralBryant Ranch Prepack63629-8757
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC67544-657
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralBryant Ranch Prepack72162-1521

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