Gabapentin
- Product NDC
- 68094-489
- 11-digit product format
- 680940489
- Labeler code
- 68094
- Product ID
- 68094-489_471ad25b-0c63-489c-9df3-44ea7fdcd256
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA207057
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- Substance
- GABAPENTIN
- Active strength
- 800 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310433, 310434 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-489-50 | Gabapentin | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 2 |
| 68094-489-60 | Gabapentin | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-489 | GABAPENTIN TABLET, COATED [PRECISION DOSE, INC.] | 2 | Current NDC, 2 package rows | 20250313_86c93d8b-6286-44e2-93dd-f1b10a5d83da.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68094-489-50 | 68094048950 | 100 TABLET, COATED in 1 BOTTLE (68094-489-50) | 2024-02-15 | No | No | Historical |
| 68094-489-60 | 68094048960 | 500 TABLET, COATED in 1 BOTTLE (68094-489-60) | 2024-02-15 | No | No | Historical |