NDC codes

FDA NDC Directory
Product NDC (as listed)42291-062Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0062Add 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
42291-062-0142291006201100 CAPSULE in 1 BOTTLE (42291-062-01)Marketed from Jun 9, 2023

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)
Isradipine
Generic name (nonproprietary)
isradipine
Active ingredients
Isradipine — 2.5 mg/1
Dosage form
Capsule
Route
Oral
Labeler
AvKARENDC labeler code 42291
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077317
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 42291-062_485b4749-5065-6c1c-e063-6294a90ade38SPL ID 485b4749-5065-6c1c-e063-6294a90ade38SPL set ID fdb4c50e-6e6f-a43d-e053-6294a90aa24fRxCUI 197848UNII YO1UK1S598UPC 0342291062016
Pharmacologic class
Dihydropyridine Calcium Channel Blocker

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

N442291006201 followed by a unit qualifier and the quantity

Package 42291-0062-01. 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 Hypertension Isradipine is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-062

What is NDC 42291-062?
42291-062 is the product NDC for Isradipine, Isradipine 2.5 mg/1 capsule, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Isradipine.
What is the active ingredient?
Isradipine.
Who is the labeler?
AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Isradipine?
4 other product NDCs are listed under this name. See all Isradipine 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 Isradipine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IsradipineIsradipine 2.5 mg/1CapsuleOralElite Laboratories, Inc.64850-91064850-0910-0164850-0910-05
IsradipineIsradipine 5 mg/1CapsuleOralElite Laboratories, Inc.64850-91164850-0911-0164850-0911-05
IsradipineIsradipine 5 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.16252-54016252-0540-01
IsradipineIsradipine 2.5 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.16252-53916252-0539-01

Other NDCs under ANDA 077317

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

FDA NDC Directory listings under ANDA 077317
ProductStrengthForm · routeLabelerProduct NDC
IsradipineIsradipine 2.5 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.16252-539
IsradipineIsradipine 5 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.16252-540

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