Lyrica
- Product NDC
- 35356-053
- 11-digit product format
- 353560053
- Labeler code
- 35356
- Product ID
- 35356-053_9c3cc965-5bbd-47bb-b082-8a0f1e658ea6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC
- Application
- NDA021724
- Marketing category
- NDA
- Marketing start
- 2011-07-18
- Marketing end
- 0000-00-00
- Substance
- PREGABALIN
- Active strength
- 25 mg/1
- DEA schedule
- CV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
Source provenance: Browse the complete Orange Book source catalog.
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 35356-053-60 | 2025-01-14 | C162847 | 48780-1 | 97449f38-d355-f6ea-e053-dbdaa90aa703 | These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 |
| 35356-053-90 | 2025-01-14 | C162847 | 48780-1 | 97449f38-d355-f6ea-e053-dbdaa90aa703 | These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 |
| 35356-053-60 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d355-f6ea-e053-dbdaa90aa703 | These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 |
| 35356-053-90 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d355-f6ea-e053-dbdaa90aa703 | These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 |
DailyMed Socrata Ingredients#