Prescription drug · ANDA
Galantamine NDC 70436-005
Galantamine hydrobromide 8 mg/1 · Tablet, Film coated · Oral · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-005-06 | 7043600050670436000506 | 60 TABLET, FILM COATED in 1 BOTTLE (70436-005-06)Marketed from Aug 2, 2017 |
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
- Slate Run Pharmaceuticals, LLCNDC labeler code 70436
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077604
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 70436-005_533c1fab-f502-439d-e063-6394a90a8c32SPL ID 533c1fab-f502-439d-e063-6394a90a8c32SPL set ID 56f365e5-0a23-4f69-e054-00144ff8d46cRxCUI 310436, 310437, 579148UNII MJ4PTD2VVWUPC 0370436006069, 0370436004065, 0370436005062
- 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
N470436000506followed by a unit qualifier and the quantityPackage 70436-0005-06. 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 Tables 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 70436-005
- What is NDC 70436-005?
- 70436-005 is the product NDC for Galantamine, Galantamine hydrobromide 8 mg/1 tablet, film coated, listed with the FDA by Slate Run Pharmaceuticals, LLC. 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?
- Slate Run Pharmaceuticals, LLC, NDC labeler code 70436. 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?
- 17 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 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 |
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-049 | 57237-0049-60 |
Other NDCs under ANDA 077604
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 4 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-722 |
| Galantamine | Galantamine hydrobromide 8 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-723 |
| Galantamine | Galantamine hydrobromide 12 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-724 |
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-906 |
| Galantamine | Galantamine hydrobromide 8 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-907 |
| Galantamine | Galantamine hydrobromide 12 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-908 |
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-004 |
| Galantamine | Galantamine hydrobromide 12 mg/1 | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-006 |