Gabapentin
- Product NDC
- 71205-485
- 11-digit product format
- 712050485
- Labeler code
- 71205
- Product ID
- 71205-485_5ebc3c8b-7e36-4c3c-807a-110b2a21c639
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090858
- Marketing category
- ANDA
- Marketing start
- 2011-01-29
- Substance
- GABAPENTIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], 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
- 71205-485_5ebc3c8b-7e36-4c3c-807a-110b2a21c639
- SPL ID
- 5ebc3c8b-7e36-4c3c-807a-110b2a21c639
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Gabapentin
- Generic name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2011-01-29
- Marketing category
- ANDA
- Application number
- ANDA090858
- Pharmacologic classes
- Anti-epileptic Agent [EPC]; 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 | 176c5b60-93c2-4574-8b51-c15180912aaa |
| Manufacturer Name | Proficient Rx LP |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71205-485-30 | 30 CAPSULE in 1 BOTTLE (71205-485-30) | 2020-10-14 | No |
| 71205-485-60 | 60 CAPSULE in 1 BOTTLE (71205-485-60) | 2020-10-14 | No |
| 71205-485-72 | 120 CAPSULE in 1 BOTTLE (71205-485-72) | 2020-10-14 | No |
| 71205-485-90 | 90 CAPSULE in 1 BOTTLE (71205-485-90) | 2020-10-14 | No |
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 |
|---|
| 71205-485-30 | 71205048530 | 30 CAPSULE in 1 BOTTLE (71205-485-30) | 30 capsule | 2020-10-14 | No | No | Historical |
| 71205-485-60 | 71205048560 | 60 CAPSULE in 1 BOTTLE (71205-485-60) | 60 capsule | 2020-10-14 | No | No | Historical |
| 71205-485-72 | 71205048572 | 120 CAPSULE in 1 BOTTLE (71205-485-72) | 120 capsule | 2020-10-14 | No | No | Historical |
| 71205-485-90 | 71205048590 | 90 CAPSULE in 1 BOTTLE (71205-485-90) | 90 capsule | 2020-10-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Gabapentin | Proficient Rx LP | 2022-08-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |