Gralise
- Product NDC
- 13913-005
- 11-digit product format
- 139130005
- Labeler code
- 13913
- Product ID
- 13913-005_b7c67fdf-a947-292f-eef0-033f21d9616d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Assertio Therapeutics, Inc.
- Application
- NDA022544
- Marketing category
- NDA
- Marketing start
- 2011-01-28
- Marketing end
- 2023-09-30
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- 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 |
|---|
| 13913-005-19 | 13913000519 | 90 TABLET, FILM COATED in 1 BOTTLE (13913-005-19) | 2011-01-28 | 2023-09-30 | No | No | Current |