lyrica

Generic: pregabalin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lyrica
Generic Name pregabalin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 50 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-263
Product ID 43353-263_46aed802-1b67-48f3-bf67-5a1c7a49cc46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021446
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2004-12-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353263
Hyphenated Format 43353-263

Supplemental Identifiers

RxCUI
483438 483440 483444 483446 483448 483450 577127 607018 607020 607022 607024 607028 607033 607038
UNII
55JG375S6M

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lyrica (source: ndc)
Generic Name pregabalin (source: ndc)
Application Number NDA021446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (43353-263-53)
source: ndc

Packages (1)

43353-263-53 60 CAPSULE in 1 BOTTLE, PLASTIC (43353-263-53)

Ingredients (1)

pregabalin (50 mg/1)

Linked Drug Pages (1)

Lyrica ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46aed802-1b67-48f3-bf67-5a1c7a49cc46", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483444", "483446", "483448", "483450", "577127", "607018", "607020", "607022", "607024", "607028", "607033", "607038"], "spl_set_id": ["fc26526a-101c-41ca-8116-3e9e33cb1600"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (43353-263-53)", "package_ndc": "43353-263-53", "marketing_start_date": "20081219"}], "brand_name": "Lyrica", "product_id": "43353-263_46aed802-1b67-48f3-bf67-5a1c7a49cc46", "dosage_form": "CAPSULE", "product_ndc": "43353-263", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lyrica", "active_ingredients": [{"name": "PREGABALIN", "strength": "50 mg/1"}], "application_number": "NDA021446", "marketing_category": "NDA", "marketing_start_date": "20041230", "listing_expiration_date": "20261231"}