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 71610-758
Product ID 71610-758_43388205-9926-420f-99ca-4882e24a9fad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209357
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 71610758
Hyphenated Format 71610-758

Supplemental Identifiers

RxCUI
483446 483450 577127
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 ANDA209357 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-758-30)
  • 56 CAPSULE in 1 BOTTLE (71610-758-46)
  • 60 CAPSULE in 1 BOTTLE (71610-758-53)
  • 90 CAPSULE in 1 BOTTLE (71610-758-60)
source: ndc

Packages (4)

71610-758-30 30 CAPSULE in 1 BOTTLE (71610-758-30) 71610-758-46 56 CAPSULE in 1 BOTTLE (71610-758-46) 71610-758-53 60 CAPSULE in 1 BOTTLE (71610-758-53) 71610-758-60 90 CAPSULE in 1 BOTTLE (71610-758-60)

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": "43388205-9926-420f-99ca-4882e24a9fad", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483446", "483450", "577127"], "spl_set_id": ["d2a98872-1a52-47e1-b4bd-0ff7d6272a92"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-758-30)", "package_ndc": "71610-758-30", "marketing_start_date": "20231130"}, {"sample": false, "description": "56 CAPSULE in 1 BOTTLE (71610-758-46)", "package_ndc": "71610-758-46", "marketing_start_date": "20231130"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-758-53)", "package_ndc": "71610-758-53", "marketing_start_date": "20231130"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-758-60)", "package_ndc": "71610-758-60", "marketing_start_date": "20231130"}], "brand_name": "Pregabalin", "product_id": "71610-758_43388205-9926-420f-99ca-4882e24a9fad", "dosage_form": "CAPSULE", "product_ndc": "71610-758", "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": "ANDA209357", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}