Lyrica
- Product NDC
- 43353-414
- 11-digit product format
- 433530414
- Labeler code
- 43353
- Product ID
- 43353-414_46aed802-1b67-48f3-bf67-5a1c7a49cc46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021446
- Marketing category
- NDA
- Marketing start
- 2004-12-30
- Marketing end
- 0000-00-00
- Substance
- PREGABALIN
- Active strength
- 150 mg/1
- DEA schedule
- CV
- 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 |
|---|
| PREGABALIN | ACTIVE INGREDIENT | 55JG375S6M | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| PREGABALIN | ACTIVE MOIETY | 55JG375S6M | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-414 | LYRICA (PREGABALIN) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC | 20171128_fc26526a-101c-41ca-8116-3e9e33cb1600.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-414-30 | 43353041430 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43353-414-30) | 30 capsule | 2017-11-03 | 0000-00-00 | No | No | Current |
| 43353-414-46 | 43353041446 | 56 CAPSULE in 1 BOTTLE, PLASTIC (43353-414-46) | 56 capsule | 2017-11-03 | 0000-00-00 | No | No | Current |
| 43353-414-53 | 43353041453 | 60 CAPSULE in 1 BOTTLE, PLASTIC (43353-414-53) | 60 capsule | 2008-12-19 | 0000-00-00 | No | No | Current |
| 43353-414-70 | 43353041470 | 120 CAPSULE in 1 BOTTLE, PLASTIC (43353-414-70) | 120 capsule | 2017-05-22 | 0000-00-00 | No | No | Current |