pregabalin

Generic: pregabalin

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

Drug Facts

Product Profile

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

pregabalin 75 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-765
Product ID 71610-765_769837cd-84ec-44df-b144-d3366847e9e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211384
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-07-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610765
Hyphenated Format 71610-765

Supplemental Identifiers

RxCUI
483450
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 pregabalin (source: ndc)
Generic Name pregabalin (source: ndc)
Application Number ANDA211384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-765-30)
  • 56 CAPSULE in 1 BOTTLE (71610-765-46)
  • 60 CAPSULE in 1 BOTTLE (71610-765-53)
  • 120 CAPSULE in 1 BOTTLE (71610-765-70)
  • 150 CAPSULE in 1 BOTTLE (71610-765-75)
  • 180 CAPSULE in 1 BOTTLE (71610-765-80)
source: ndc

Packages (6)

71610-765-30 30 CAPSULE in 1 BOTTLE (71610-765-30) 71610-765-46 56 CAPSULE in 1 BOTTLE (71610-765-46) 71610-765-53 60 CAPSULE in 1 BOTTLE (71610-765-53) 71610-765-70 120 CAPSULE in 1 BOTTLE (71610-765-70) 71610-765-75 150 CAPSULE in 1 BOTTLE (71610-765-75) 71610-765-80 180 CAPSULE in 1 BOTTLE (71610-765-80)

Ingredients (1)

pregabalin (75 mg/1)

Linked Drug Pages (1)

Pregabalin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "769837cd-84ec-44df-b144-d3366847e9e0", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483450"], "spl_set_id": ["ef7c2e2c-c314-4bfd-a9fa-39f0b0884d34"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-765-30)", "package_ndc": "71610-765-30", "marketing_start_date": "20231220"}, {"sample": false, "description": "56 CAPSULE in 1 BOTTLE (71610-765-46)", "package_ndc": "71610-765-46", "marketing_start_date": "20231220"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-765-53)", "package_ndc": "71610-765-53", "marketing_start_date": "20231220"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71610-765-70)", "package_ndc": "71610-765-70", "marketing_start_date": "20231220"}, {"sample": false, "description": "150 CAPSULE in 1 BOTTLE (71610-765-75)", "package_ndc": "71610-765-75", "marketing_start_date": "20250708"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-765-80)", "package_ndc": "71610-765-80", "marketing_start_date": "20250708"}], "brand_name": "Pregabalin", "product_id": "71610-765_769837cd-84ec-44df-b144-d3366847e9e0", "dosage_form": "CAPSULE", "product_ndc": "71610-765", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "75 mg/1"}], "application_number": "ANDA211384", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}