Prescription drug · ANDA

Hydralazine Hydrochloride NDC 60687-833

Hydralazine hydrochloride 50 mg/1 · Tablet · Oral · American Health Packaging

NDC codes

FDA NDC Directory
Product NDC (as listed)60687-833Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0833Add 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
60687-833-0160687083301100 BLISTER PACK in 1 CARTON (60687-833-01) / 1 TABLET in 1 BLISTER PACK (60687-833-11)Marketed from Mar 15, 2024

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
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 60687-833_22cbafb8-fd5b-19b1-e063-6394a90a2b4eSPL ID 22cbafb8-fd5b-19b1-e063-6394a90a2b4eSPL set ID 2e82655e-8435-46fa-b734-8e7c6e803453RxCUI 905199, 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

N460687083301 followed by a unit qualifier and the quantity

Package 60687-0833-01. 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)

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 100 mg/1TabletOralMajor Pharmaceuticals0904-7450
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 10 mg/1TabletOralAmerican Health Packaging60687-811
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralAmerican Health Packaging60687-822
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralCoupler LLC67046-1520
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralNorthwind Health Company, LLC82868-045
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-833
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-832
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/1TabletOralREMEDYREPACK INC.70518-4007
Hydralazine HydrochlorideHydralazine hydrochloride 10 mg/1TabletOralREMEDYREPACK INC.70518-4022
Hydralazine HydrochlorideHydralazine hydrochloride 100 mg/1TabletOralREMEDYREPACK INC.70518-4352
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-4064
Hydralazine HydrochlorideHydralazine hydrochloride 50 mg/1TabletOralCardinal Health 107, LLC55154-2140
Hydralazine HydrochlorideHydralazine hydrochloride 25 mg/1TabletOralCardinal Health 107, LLC55154-2141

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Hydralazine Hydrochloride NDC 60687-833 | Med-Code