pregabalin
Generic: pregabalin
Labeler: aphena pharma solutions - tennessee, llcDrug Facts
Product Profile
Brand Name
pregabalin
Generic Name
pregabalin
Labeler
aphena pharma solutions - tennessee, llc
Dosage Form
CAPSULE
Routes
Active Ingredients
pregabalin 50 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
71610-882
Product ID
71610-882_85053f33-9372-4fd6-b67b-0e7cc1b063c5
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
71610882
Hyphenated Format
71610-882
Supplemental Identifiers
RxCUI
UNII
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
source: ndc
Resolved Composition
Strengths
- 50 mg/1
Packaging
- 56 CAPSULE in 1 BOTTLE (71610-882-46)
- 60 CAPSULE in 1 BOTTLE (71610-882-53)
Packages (2)
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "85053f33-9372-4fd6-b67b-0e7cc1b063c5", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483448"], "spl_set_id": ["b0f34220-0657-4868-ae01-014f9300f622"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "56 CAPSULE in 1 BOTTLE (71610-882-46)", "package_ndc": "71610-882-46", "marketing_start_date": "20250224"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-882-53)", "package_ndc": "71610-882-53", "marketing_start_date": "20250224"}], "brand_name": "Pregabalin", "product_id": "71610-882_85053f33-9372-4fd6-b67b-0e7cc1b063c5", "dosage_form": "CAPSULE", "product_ndc": "71610-882", "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": "50 mg/1"}], "application_number": "ANDA209357", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}