miglustat
- Product NDC
- 51991-959
- 11-digit product format
- 519910959
- Labeler code
- 51991
- Product ID
- 51991-959_88e64165-dd9a-4308-918d-4f91d643f802
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Miglustat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA209325
- Marketing category
- ANDA
- Marketing start
- 2022-03-01
- Marketing end
- 0000-00-00
- Substance
- MIGLUSTAT
- Active strength
- 100 mg/1
- Pharmacologic classes
- Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 51991-959 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 51991-959 | 51991-959-90 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A209325-001 | MIGLUSTAT | MIGLUSTAT | 100MG | CAPSULE / ORAL | | | 2022-02-03 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51991-959-90 | 51991095990 | 90 CAPSULE in 1 BOTTLE (51991-959-90) | 90 capsule | 2022-03-01 | 0000-00-00 | No | No | Current |