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 71610-936
Product ID 71610-936_3c6d5d78-6f10-a921-e063-6294a90a3f9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208677
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 71610936
Hyphenated Format 71610-936

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 (71610-936-30)
  • 56 CAPSULE in 1 BOTTLE (71610-936-46)
  • 60 CAPSULE in 1 BOTTLE (71610-936-53)
  • 270 CAPSULE in 1 BOTTLE (71610-936-92)
source: ndc

Packages (4)

71610-936-30 30 CAPSULE in 1 BOTTLE (71610-936-30) 71610-936-46 56 CAPSULE in 1 BOTTLE (71610-936-46) 71610-936-53 60 CAPSULE in 1 BOTTLE (71610-936-53) 71610-936-92 270 CAPSULE in 1 BOTTLE (71610-936-92)

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": "3c6d5d78-6f10-a921-e063-6294a90a3f9b", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438"], "spl_set_id": ["3c6daa12-5284-d9f1-e063-6294a90ae060"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-936-30)", "package_ndc": "71610-936-30", "marketing_start_date": "20250815"}, {"sample": false, "description": "56 CAPSULE in 1 BOTTLE (71610-936-46)", "package_ndc": "71610-936-46", "marketing_start_date": "20250815"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-936-53)", "package_ndc": "71610-936-53", "marketing_start_date": "20250815"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE (71610-936-92)", "package_ndc": "71610-936-92", "marketing_start_date": "20250815"}], "brand_name": "Pregabalin", "product_id": "71610-936_3c6d5d78-6f10-a921-e063-6294a90a3f9b", "dosage_form": "CAPSULE", "product_ndc": "71610-936", "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": "20190719", "listing_expiration_date": "20261231"}