Prescription drug · ANDA
Galantamine NDC 68084-729
Galantamine hydrobromide 4 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-729-21 | 68084072921 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-729-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-729-11)Marketed from Jul 3, 2014 |
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 — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 68084
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090957
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 68084-729_2864c9b5-d581-daf1-e063-6394a90a2923SPL ID 2864c9b5-d581-daf1-e063-6394a90a2923SPL set ID e80ec152-3616-4a13-9266-715550a8c398RxCUI 310436UNII MJ4PTD2VVW
- 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
N468084072921followed by a unit qualifier and the quantityPackage 68084-0729-21. 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 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.
About NDC 68084-729
- What is NDC 68084-729?
- 68084-729 is the product NDC for Galantamine, Galantamine hydrobromide 4 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. It has 1 package NDC, 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?
- American Health Packaging, NDC labeler code 68084. 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 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 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2566 | 72162-2566-06 |
Other NDCs under ANDA 090957
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 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 8 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-459 |
| 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 |