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 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-808
Product ID 71610-808_4229e9d6-f6fb-ce42-e063-6294a90a09c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208677
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2021-08-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610808
Hyphenated Format 71610-808

Supplemental Identifiers

RxCUI
483438
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 ANDA208677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-808-30)
  • 60 CAPSULE in 1 BOTTLE (71610-808-53)
  • 84 CAPSULE in 1 BOTTLE (71610-808-54)
  • 90 CAPSULE in 1 BOTTLE (71610-808-60)
  • 120 CAPSULE in 1 BOTTLE (71610-808-70)
  • 150 CAPSULE in 1 BOTTLE (71610-808-75)
  • 180 CAPSULE in 1 BOTTLE (71610-808-80)
source: ndc

Packages (7)

71610-808-30 30 CAPSULE in 1 BOTTLE (71610-808-30) 71610-808-53 60 CAPSULE in 1 BOTTLE (71610-808-53) 71610-808-54 84 CAPSULE in 1 BOTTLE (71610-808-54) 71610-808-60 90 CAPSULE in 1 BOTTLE (71610-808-60) 71610-808-70 120 CAPSULE in 1 BOTTLE (71610-808-70) 71610-808-75 150 CAPSULE in 1 BOTTLE (71610-808-75) 71610-808-80 180 CAPSULE in 1 BOTTLE (71610-808-80)

Ingredients (1)

pregabalin (100 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": "4229e9d6-f6fb-ce42-e063-6294a90a09c0", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438"], "spl_set_id": ["14c00449-c3b8-d6ba-e063-6294a90ab627"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-808-30)", "package_ndc": "71610-808-30", "marketing_start_date": "20240326"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-808-53)", "package_ndc": "71610-808-53", "marketing_start_date": "20240326"}, {"sample": false, "description": "84 CAPSULE in 1 BOTTLE (71610-808-54)", "package_ndc": "71610-808-54", "marketing_start_date": "20251024"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-808-60)", "package_ndc": "71610-808-60", "marketing_start_date": "20240326"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71610-808-70)", "package_ndc": "71610-808-70", "marketing_start_date": "20240326"}, {"sample": false, "description": "150 CAPSULE in 1 BOTTLE (71610-808-75)", "package_ndc": "71610-808-75", "marketing_start_date": "20251024"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-808-80)", "package_ndc": "71610-808-80", "marketing_start_date": "20251024"}], "brand_name": "Pregabalin", "product_id": "71610-808_4229e9d6-f6fb-ce42-e063-6294a90a09c0", "dosage_form": "CAPSULE", "product_ndc": "71610-808", "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": "100 mg/1"}], "application_number": "ANDA208677", "marketing_category": "ANDA", "marketing_start_date": "20210824", "listing_expiration_date": "20261231"}