What is NDC 65862-459?

65862-459 is the product NDC for Galantamine, Galantamine hydrobromide 8 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Galantamine?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Galantamine NDC 65862-459 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-459Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0459Add 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
65862-459-60	65862045960	60 TABLET, FILM COATED in 1 BOTTLE (65862-459-60)Marketed from Mar 29, 2011
65862-459-71	65862045971	7000 TABLET, FILM COATED in 1 BOTTLE (65862-459-71)Marketed from Mar 29, 2011
65862-459-99	65862045999	1000 TABLET, FILM COATED in 1 BOTTLE (65862-459-99)Marketed from Mar 29, 2011

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): Galantamine
Generic name (nonproprietary): galantamine
Active ingredients: Galantamine hydrobromide — 8 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090957
Marketing start: Mar 29, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 65862-459_a5420811-7ce9-4ea6-8d93-6422f016b0d8SPL ID a5420811-7ce9-4ea6-8d93-6422f016b0d8SPL set ID 4e05d1da-0eb8-4fe0-8259-f1ebb170e0dcRxCUI 310436, 310437, 579148UNII MJ4PTD2VVWUPC 0365862460608
Pharmacologic class: Cholinesterase Inhibitor

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

N465862045960 followed by a unit qualifier and the quantity

Package 65862-0459-60. 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 Feb 8, 2024.

Indications (excerpt from the label)

Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine tablets are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-459

What is NDC 65862-459?: 65862-459 is the product NDC for Galantamine, Galantamine hydrobromide 8 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Galantamine.
What is the active ingredient?: Galantamine hydrobromide.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Galantamine?: 20 other product NDCs are listed under this name. See all Galantamine 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 Galantamine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Galantamine	Galantamine hydrobromide 4 mg/1	Tablet, Film coatedOral	Upsher-Smith Laboratories, LLC	24979-722	24979-0722-04
Galantamine	Galantamine hydrobromide 8 mg/1	Tablet, Film coatedOral	Upsher-Smith Laboratories, LLC	24979-723	24979-0723-04
Galantamine	Galantamine hydrobromide 12 mg/1	Tablet, Film coatedOral	Upsher-Smith Laboratories, LLC	24979-724	24979-0724-04
Galantamine	Galantamine hydrobromide 4 mg/1	Tablet, Film coatedOral	Slate Run Pharmaceuticals, LLC	70436-004	70436-0004-06
Galantamine	Galantamine hydrobromide 8 mg/1	Tablet, Film coatedOral	Slate Run Pharmaceuticals, LLC	70436-005	70436-0005-06
Galantamine	Galantamine hydrobromide 12 mg/1	Tablet, Film coatedOral	Slate Run Pharmaceuticals, LLC	70436-006	70436-0006-06
Galantamine	Galantamine hydrobromide 8 mg/1	Capsule, Extended releaseOral	Aurobindo Pharma Limited	65862-744	65862-0744-0165862-0744-0565862-0744-30+2 more
Galantamine	Galantamine hydrobromide 16 mg/1	Capsule, Extended releaseOral	Aurobindo Pharma Limited	65862-745	65862-0745-0165862-0745-0565862-0745-30+2 more
Galantamine	Galantamine hydrobromide 24 mg/1	Capsule, Extended releaseOral	Aurobindo Pharma Limited	65862-746	65862-0746-0165862-0746-0565862-0746-30+2 more
Galantamine	Galantamine hydrobromide 4 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-729	68084-0729-21

All 21 Galantamine NDCs

Other NDCs under ANDA 090957

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

FDA NDC Directory listings under ANDA 090957
Product	Strength	Form · route	Labeler	Product NDC
Galantamine	Galantamine hydrobromide 4 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-729
Galantamine	Galantamine hydrobromide 8 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2566
Galantamine	Galantamine hydrobromide 4 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-458
Galantamine	Galantamine hydrobromide 12 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-460
Galantamine	Galantamine hydrobromide 4 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-049
Galantamine	Galantamine hydrobromide 8 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-050
Galantamine	Galantamine hydrobromide 12 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-051
Galantamine	Galantamine hydrobromide 4 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2766