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 300 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-320
Product ID 71610-320_9d6ac8b5-77e4-4c4f-9c24-8d3043149146
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 71610320
Hyphenated Format 71610-320

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 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 ANDA211384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-320-30)
  • 56 CAPSULE in 1 BOTTLE (71610-320-46)
  • 60 CAPSULE in 1 BOTTLE (71610-320-53)
source: ndc

Packages (3)

71610-320-30 30 CAPSULE in 1 BOTTLE (71610-320-30) 71610-320-46 56 CAPSULE in 1 BOTTLE (71610-320-46) 71610-320-53 60 CAPSULE in 1 BOTTLE (71610-320-53)

Ingredients (1)

pregabalin (300 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": "9d6ac8b5-77e4-4c4f-9c24-8d3043149146", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["bf710bcf-75ed-4184-b9c3-81cd05a780a4"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-320-30)", "package_ndc": "71610-320-30", "marketing_start_date": "20190812"}, {"sample": false, "description": "56 CAPSULE in 1 BOTTLE (71610-320-46)", "package_ndc": "71610-320-46", "marketing_start_date": "20240108"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-320-53)", "package_ndc": "71610-320-53", "marketing_start_date": "20190812"}], "brand_name": "Pregabalin", "product_id": "71610-320_9d6ac8b5-77e4-4c4f-9c24-8d3043149146", "dosage_form": "CAPSULE", "product_ndc": "71610-320", "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": "300 mg/1"}], "application_number": "ANDA211384", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}