RELGAABI
- Product NDC
- 58657-233
- 11-digit product format
- 586570233
- Labeler code
- 58657
- Product ID
- 58657-233_4ef62c9f-cf61-6ad7-e063-6394a90a2774
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2026-04-15
- Substance
- GABAPENTIN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RELGAABI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310431, 310432, 2739001, 2739007, 2740839, 2740841 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58657-233-01 | RELGAABI | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58657-233-01 | 58657023301 | 100 CAPSULE in 1 BOTTLE, PLASTIC (58657-233-01) | 100 capsule | 2026-04-15 | No | No | Historical |