Lyrica
- Product NDC
- 35356-398
- 11-digit product format
- 353560398
- Labeler code
- 35356
- Product ID
- 35356-398_2a66e7d2-5587-4796-9066-84aeee560d84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- NDA021724
- Marketing category
- NDA
- Marketing start
- 2010-08-13
- Marketing end
- 0000-00-00
- Substance
- PREGABALIN
- Active strength
- 300 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 35356-398 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 35356-398 | 35356-398-60 | D | Discontinued by firm | 2026-07-31 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 35356-398-60 | 2025-01-08 | C162847 | 48780-1 | ba0f9c33-2e4a-a910-e053-dadaa90a0b85 | LYRICA 300 mg |
| 35356-398-60 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2e4a-a910-e053-dadaa90a0b85 | LYRICA 300 mg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-398-60 | EA - Each | 35356-398 | 04d00a68-af48-4e5d-a54c-1709b9c5ebfd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PREGABALIN | ACTIVE INGREDIENT | 55JG375S6M | LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 350 | |
| PREGABALIN | ACTIVE MOIETY | 55JG375S6M | LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 350 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 350 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 350 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 350 |