Prescription drug · ANDA

Hydralazine Hydrochloride NDC 71335-9722

Hydralazine hydrochloride 100 mg/1 · Tablet · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9722Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9722Add 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
71335-9722-1713359722017133597220130 TABLET in 1 BOTTLE (71335-9722-1)Marketed from May 30, 2023
71335-9722-2713359722027133597220260 TABLET in 1 BOTTLE (71335-9722-2)Marketed from May 30, 2023
71335-9722-3713359722037133597220390 TABLET in 1 BOTTLE (71335-9722-3)Marketed from May 30, 2023

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 — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205236
Marketing start
Listing expires
Other FDA classes
Arteriolar Vasodilation (Physiologic effect)
Identifiers
Product ID 71335-9722_58bc1add-d89b-4604-811f-3bc0534658aaSPL ID 58bc1add-d89b-4604-811f-3bc0534658aaSPL set ID d4509f69-e60e-4440-957b-5c2714480335RxCUI 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

N471335972201 followed by a unit qualifier and the quantity

Package 71335-9722-01. 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 .

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 71335-9722

What is NDC 71335-9722?
71335-9722 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 100 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 205236

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

FDA NDC Directory listings under ANDA 205236
ProductStrengthForm · routeLabelerProduct NDC
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralA-S Medication Solutions50090-7210
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralA-S Medication Solutions50090-7212
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-182
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-183
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-184
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-185
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralBryant Ranch Prepack63629-8493
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralBryant Ranch Prepack63629-8494
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralBryant Ranch Prepack63629-8495
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralBryant Ranch Prepack63629-8496
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralBryant Ranch Prepack63629-8497
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralCoupler LLC67046-1609
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralCoupler LLC67046-1660
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-3852
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-2307
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralBryant Ranch Prepack71335-2352
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralBryant Ranch Prepack71335-9756
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-549
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-561
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-562

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