Gabapentin
- Product NDC
- 65862-523
- 11-digit product format
- 658620523
- Labeler code
- 65862
- Product ID
- 65862-523_700d09f5-99cc-492d-ab49-442f674d9c5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA200651
- Marketing category
- ANDA
- Marketing start
- 2011-10-06
- Substance
- GABAPENTIN
- Active strength
- 600 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 | 600 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 |
|---|
| 65862-523-01 | Gabapentin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 20 |
| 65862-523-05 | Gabapentin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 20 |
| 65862-523-26 | Gabapentin | 2500 in 1 BOTTLE | TABLET, FILM COATED | 2500 | | 20 |
| 65862-523-90 | Gabapentin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| COPOVIDONE | INACTIVE INGREDIENT | D9C330MD8B | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-523 | GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 20 | Current NDC, Legacy NDC, 4 package rows | 20250524_25cf6c40-a239-4dd0-9cad-28da84d285db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-523-01 | 65862052301 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-523-01) | 2011-10-06 | 0000-00-00 | No | No | Current |
| 65862-523-05 | 65862052305 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-523-05) | 2011-10-06 | 0000-00-00 | No | No | Current |
| 65862-523-26 | 65862052326 | 2500 TABLET, FILM COATED in 1 BOTTLE (65862-523-26) | 2011-10-06 | 0000-00-00 | No | No | Current |
| 65862-523-90 | 65862052390 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-523-90) | 2011-10-06 | 0000-00-00 | No | No | Current |