Gabapentin
- Product NDC
- 71335-2478
- 11-digit product format
- 713352478
- Labeler code
- 71335
- Product ID
- 71335-2478_2973d72c-9629-418f-8443-47ca3a54d352
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213603
- Marketing category
- ANDA
- Marketing start
- 2021-05-03
- Substance
- GABAPENTIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2478_2973d72c-9629-418f-8443-47ca3a54d352
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Gabapentin
- Generic name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2021-05-03
- Marketing category
- ANDA
- Application number
- ANDA213603
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| GABAPENTIN | 400 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310432 |
| Spl Set Id | 2dad630a-09d8-4f40-bdad-24e877a9ee38 |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6CW7F3G59X | GABAPENTIN | 60142-96-3 | GABAPENTIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2478-0 | 71335247800 | 180 CAPSULE in 1 BOTTLE (71335-2478-0) | 180 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-1 | 71335247801 | 20 CAPSULE in 1 BOTTLE (71335-2478-1) | 20 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-2 | 71335247802 | 90 CAPSULE in 1 BOTTLE (71335-2478-2) | 90 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-3 | 71335247803 | 60 CAPSULE in 1 BOTTLE (71335-2478-3) | 60 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-4 | 71335247804 | 30 CAPSULE in 1 BOTTLE (71335-2478-4) | 30 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-5 | 71335247805 | 120 CAPSULE in 1 BOTTLE (71335-2478-5) | 120 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-6 | 71335247806 | 21 CAPSULE in 1 BOTTLE (71335-2478-6) | 21 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-7 | 71335247807 | 84 CAPSULE in 1 BOTTLE (71335-2478-7) | 84 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-8 | 71335247808 | 112 CAPSULE in 1 BOTTLE (71335-2478-8) | 112 capsule | 2024-09-03 | No | No | Current |
| 71335-2478-9 | 71335247809 | 28 CAPSULE in 1 BOTTLE (71335-2478-9) | 28 capsule | 2024-09-03 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Bryant Ranch Prepack | 2024-09-03 | HUMAN PRESCRIPTION DRUG LABEL | 1 |