Gabapentin
- Product NDC
- 65841-706
- 11-digit product format
- 658410706
- Labeler code
- 65841
- Product ID
- 65841-706_e9f9a5e6-0454-4601-90e4-b170bb325eb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA078926
- Marketing category
- ANDA
- Marketing start
- 2012-10-16
- 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 |
|---|
| 65841-706-01 | Gabapentin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 65841-706-05 | Gabapentin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 65841-706-10 | Gabapentin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
| 65841-706-77 | Gabapentin | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
| 65841-706-77 | Gabapentin | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| COPOVIDONE | INACTIVE INGREDIENT | D9C330MD8B | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-706 | GABAPENTIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 8 | Current NDC, Legacy NDC, 5 package rows | 20241201_b033c169-4943-4ad9-ace0-7e4a1f0dc100.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-706-01 | 65841070601 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-706-01) | | 2012-10-16 | 0000-00-00 | No | No | Current |
| 65841-706-05 | 65841070605 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-706-05) | | 2012-10-16 | 0000-00-00 | No | No | Current |
| 65841-706-10 | 65841070610 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-706-10) | | 2012-10-16 | 0000-00-00 | No | No | Current |
| 65841-706-77 | 65841070677 | 10 BLISTER PACK in 1 CARTON (65841-706-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-10-16 | 0000-00-00 | No | No | Current |