RAZADYNE
- Product NDC
- 50458-387
- 11-digit product format
- 504580387
- Labeler code
- 50458
- Product ID
- 50458-387_7eab135b-9825-43c2-b70a-13c1eef3557d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- galantamine hydrobromide
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA021615
- Marketing category
- NDA
- Marketing start
- 2004-12-24
- Marketing end
- 2023-05-31
- Substance
- GALANTAMINE HYDROBROMIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50458-387-30 | 50458038730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50458-387-30) | 2004-12-24 | 2023-05-31 | No | No | Current |