pregabalin

Generic: pregabalin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 100 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8360
Product ID 68788-8360_582d8992-18e4-4886-bc7d-d668fa763e44
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207799
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888360
Hyphenated Format 68788-8360

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 ANDA207799 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BLISTER PACK (68788-8360-1)
  • 30 CAPSULE in 1 BOTTLE (68788-8360-3)
  • 60 CAPSULE in 1 BOTTLE (68788-8360-6)
  • 90 CAPSULE in 1 BOTTLE (68788-8360-9)
source: ndc

Packages (4)

68788-8360-1 100 CAPSULE in 1 BLISTER PACK (68788-8360-1) 68788-8360-3 30 CAPSULE in 1 BOTTLE (68788-8360-3) 68788-8360-6 60 CAPSULE in 1 BOTTLE (68788-8360-6) 68788-8360-9 90 CAPSULE in 1 BOTTLE (68788-8360-9)

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": "582d8992-18e4-4886-bc7d-d668fa763e44", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438"], "spl_set_id": ["e8e272a4-c181-4573-822b-2bb315b6ad37"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BLISTER PACK (68788-8360-1)", "package_ndc": "68788-8360-1", "marketing_start_date": "20230201"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8360-3)", "package_ndc": "68788-8360-3", "marketing_start_date": "20230201"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8360-6)", "package_ndc": "68788-8360-6", "marketing_start_date": "20230201"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68788-8360-9)", "package_ndc": "68788-8360-9", "marketing_start_date": "20230201"}], "brand_name": "Pregabalin", "product_id": "68788-8360_582d8992-18e4-4886-bc7d-d668fa763e44", "dosage_form": "CAPSULE", "product_ndc": "68788-8360", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "100 mg/1"}], "application_number": "ANDA207799", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}