Gabapentin
- Product NDC
- 0228-2637
- 11-digit product format
- 002282637
- Labeler code
- 0228
- Product ID
- 0228-2637_aea65b96-e213-4141-8c3f-3eb4650985f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA075694
- Marketing category
- ANDA
- Marketing start
- 2004-10-04
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 800 mg/1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| CROSPOVIDONE (15 MPA.S AT 5%) | INACTIVE INGREDIENT | 68401960MK | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 18 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-2637 | GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 35 | Legacy NDC | 20241027_a33dd4d8-7d6e-4d15-ae49-9c400059c794.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0228-2637-11 | 00228263711 | 100 TABLET, FILM COATED in 1 BOTTLE (0228-2637-11) | 2004-10-04 | 0000-00-00 | No | No | Current |
| 0228-2637-50 | 00228263750 | 500 TABLET, FILM COATED in 1 BOTTLE (0228-2637-50) | 2004-10-04 | 0000-00-00 | No | No | Current |