pregabalin

Generic: pregabalin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 75 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-207
Product ID 82804-207_580955ba-86f6-4e86-b0fa-dd44e8828b0e
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 82804207
Hyphenated Format 82804-207

Supplemental Identifiers

RxCUI
483450
UPC
0382804207602
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
  • 60 CAPSULE in 1 BOTTLE (82804-207-60)
source: ndc

Packages (1)

82804-207-60 60 CAPSULE in 1 BOTTLE (82804-207-60)

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": "580955ba-86f6-4e86-b0fa-dd44e8828b0e", "openfda": {"upc": ["0382804207602"], "unii": ["55JG375S6M"], "rxcui": ["483450"], "spl_set_id": ["580955ba-86f6-4e86-b0fa-dd44e8828b0e"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (82804-207-60)", "package_ndc": "82804-207-60", "marketing_start_date": "20250312"}], "brand_name": "Pregabalin", "product_id": "82804-207_580955ba-86f6-4e86-b0fa-dd44e8828b0e", "dosage_form": "CAPSULE", "product_ndc": "82804-207", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Proficient Rx LP", "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"}