What is NDC 64850-910?

64850-910 is the product NDC for Isradipine, Isradipine 2.5 mg/1 capsule, listed with the FDA by Elite Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Elite Laboratories, Inc., NDC labeler code 64850. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isradipine NDC 64850-910 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-910Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0910Add 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 NDC	11-digit (billing)	Package	Copy
64850-910-01	64850091001	100 CAPSULE in 1 BOTTLE (64850-910-01)Marketed from Dec 28, 2022
64850-910-05	64850091005	500 CAPSULE in 1 BOTTLE (64850-910-05)Marketed from Dec 28, 2022

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: Elite Laboratories, Inc.NDC labeler code 64850
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077169
Marketing start: Dec 28, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21SPL ID 194819ab-8bf2-4f80-b9bb-a1209af1ba21SPL set ID acf7c376-6cb6-4857-b455-0bf5da29346cRxCUI 197848, 197849UNII YO1UK1S598UPC 0364850911016, 0364850910019
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

N464850091001 followed by a unit qualifier and the quantity

Package 64850-0910-01. 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 Dec 27, 2019.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hypertension Isradipine capsules are 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 64850-910

What is NDC 64850-910?: 64850-910 is the product NDC for Isradipine, Isradipine 2.5 mg/1 capsule, listed with the FDA by Elite Laboratories, Inc.. It has 2 package NDCs, 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?: Elite Laboratories, Inc., NDC labeler code 64850. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Isradipine	Isradipine 2.5 mg/1	CapsuleOral	AvKARE	42291-062	42291-0062-01
Isradipine	Isradipine 5 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-911	64850-0911-0164850-0911-05
Isradipine	Isradipine 5 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	16252-540	16252-0540-01
Isradipine	Isradipine 2.5 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	16252-539	16252-0539-01

Other NDCs under ANDA 077169

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

FDA NDC Directory listings under ANDA 077169
Product	Strength	Form · route	Labeler	Product NDC
Isradipine	Isradipine 5 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-911