Prescription drug · ANDA

Hydralazine Hydrochloride NDC 71610-562

Hydralazine hydrochloride 50 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-562Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0562Add 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
71610-562-60716100562607161005626090 TABLET in 1 BOTTLE (71610-562-60)Marketed from May 25, 2021
71610-562-807161005628071610056280180 TABLET in 1 BOTTLE (71610-562-80)Marketed from May 25, 2021
71610-562-927161005629271610056292270 TABLET in 1 BOTTLE (71610-562-92)Marketed from May 25, 2021
71610-562-987161005629871610056298540 TABLET in 1 BOTTLE (71610-562-98)Marketed from May 25, 2021

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 — 50 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
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 71610-562_547e8073-67bc-4f54-bcc9-0fb525db6687SPL ID 547e8073-67bc-4f54-bcc9-0fb525db6687SPL set ID c2638ae6-a210-490f-8389-bbed6a3229c5RxCUI 905222, 905225, 905395UNII 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

N471610056260 followed by a unit qualifier and the quantity

Package 71610-0562-60. 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 71610-562

What is NDC 71610-562?
71610-562 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 50 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?
Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 100 mg/1TabletOralBryant Ranch Prepack71335-9722
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

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