Prescription drug · ANDA

Hydralazine Hydrochloride NDC 0615-7973

Hydralazine hydrochloride 100 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-7973Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-7973Add 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
0615-7973-05006157973050061579730515 TABLET in 1 BLISTER PACK (0615-7973-05)Marketed from Nov 10, 2022
0615-7973-39006157973390061579733930 TABLET in 1 BLISTER PACK (0615-7973-39)Marketed from Jan 1, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040901
Marketing start
Listing expires
Other FDA classes
Arteriolar Vasodilation (Physiologic effect)
Identifiers
Product ID 0615-7973_502998b4-a486-4c38-ae3a-a47512d2c58cSPL ID 502998b4-a486-4c38-ae3a-a47512d2c58cSPL set ID f07abdec-6d94-45b6-be1b-10a898ea28c2RxCUI 905222UNII 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

N400615797305 followed by a unit qualifier and the quantity

Package 00615-7973-05. 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 0615-7973

What is NDC 0615-7973?
0615-7973 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 100 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 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?
NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 040901

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

FDA NDC Directory listings under ANDA 040901
ProductStrengthForm · routeLabelerProduct NDC
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-519
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-520
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-521
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-522
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-0137
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralA-S Medication Solutions50090-0139
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralA-S Medication Solutions50090-6684
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralBryant Ranch Prepack63629-5246
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-1940
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-2055
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5285
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-8087
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-2551
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralProficient Rx LP71205-091
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralBryant Ranch Prepack71335-0202
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralBryant Ranch Prepack71335-1589
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-1685
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralProficient Rx LP82804-197

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