Prescription drug · ANDA
Galantamine NDC 65862-744
Galantamine hydrobromide 8 mg/1 · Capsule, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-744-01 | 65862074401 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-01)Marketed from Aug 5, 2016 | |
| 65862-744-05 | 65862074405 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-05)Marketed from Aug 5, 2016 | |
| 65862-744-30 | 65862074430 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-30)Marketed from Aug 5, 2016 | |
| 65862-744-90 | 65862074490 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-90)Marketed from Aug 5, 2016 | |
| 65862-744-99 | 65862074499 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-99)Marketed from Aug 5, 2016 |
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
- Capsule, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204895
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-744_5b352114-093a-450c-81d1-4914dac5e2e3SPL ID 5b352114-093a-450c-81d1-4914dac5e2e3SPL set ID d0b75970-8d3d-408b-9e17-9cbad0f776b1RxCUI 860695, 860707, 860715UNII MJ4PTD2VVWUPC 0365862744302, 0365862746306, 0365862745309
- 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
N465862074401followed by a unit qualifier and the quantityPackage 65862-0744-01. 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)
Galantamine extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine extended-release capsules 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.
About NDC 65862-744
- What is NDC 65862-744?
- 65862-744 is the product NDC for Galantamine, Galantamine hydrobromide 8 mg/1 capsule, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 5 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.
Related NDCs: other Galantamine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 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 |
| Galantamine | Galantamine hydrobromide 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2566 | 72162-2566-06 |
Other NDCs under ANDA 204895
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Galantamine | Galantamine hydrobromide 16 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 65862-745 |
| Galantamine | Galantamine hydrobromide 24 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 65862-746 |