Gabapentin
- Product NDC
- 43353-863
- 11-digit product format
- 433530863
- Labeler code
- 43353
- Product ID
- 43353-863_19801231-00a9-4772-b3b1-9be1ac7c1b86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078787
- Marketing category
- ANDA
- Marketing start
- 2008-01-31
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-863 | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC | 20171029_f041f43e-dbd8-4cbf-ad77-f0d9c6b8ffa8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-863-30 | 43353086330 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-30) | 30 capsule | 2013-12-26 | 0000-00-00 | No | No | Current |
| 43353-863-53 | 43353086353 | 60 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-53) | 60 capsule | 2014-07-01 | 0000-00-00 | No | No | Current |
| 43353-863-60 | 43353086360 | 90 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-60) | 90 capsule | 2015-03-06 | 0000-00-00 | No | No | Current |
| 43353-863-70 | 43353086370 | 120 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-70) | 120 capsule | 2013-08-16 | 0000-00-00 | No | No | Current |
| 43353-863-80 | 43353086380 | 180 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-80) | 180 capsule | 2014-07-01 | 0000-00-00 | No | No | Current |
| 43353-863-92 | 43353086392 | 270 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-92) | 270 capsule | 2015-03-27 | 0000-00-00 | No | No | Current |
| 43353-863-94 | 43353086394 | 360 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-94) | 360 capsule | 2013-08-23 | 0000-00-00 | No | No | Current |
| 43353-863-98 | 43353086398 | 540 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-98) | 540 capsule | 2013-08-23 | 0000-00-00 | No | No | Current |