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 75 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8391
Product ID 68788-8391_503ffc89-4be5-4e73-8fe4-b76182f19b5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207799
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888391
Hyphenated Format 68788-8391

Supplemental Identifiers

RxCUI
483450
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
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68788-8391-1)
  • 30 CAPSULE in 1 BOTTLE (68788-8391-3)
  • 60 CAPSULE in 1 BOTTLE (68788-8391-6)
  • 90 CAPSULE in 1 BOTTLE (68788-8391-9)
source: ndc

Packages (4)

Ingredients (1)

pregabalin (75 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "503ffc89-4be5-4e73-8fe4-b76182f19b5b", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483450"], "spl_set_id": ["a0da0534-b386-4c93-ae89-03b0e3325e02"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68788-8391-1)", "package_ndc": "68788-8391-1", "marketing_start_date": "20230301"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8391-3)", "package_ndc": "68788-8391-3", "marketing_start_date": "20230301"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8391-6)", "package_ndc": "68788-8391-6", "marketing_start_date": "20230301"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68788-8391-9)", "package_ndc": "68788-8391-9", "marketing_start_date": "20230301"}], "brand_name": "Pregabalin", "product_id": "68788-8391_503ffc89-4be5-4e73-8fe4-b76182f19b5b", "dosage_form": "CAPSULE", "product_ndc": "68788-8391", "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": "75 mg/1"}], "application_number": "ANDA207799", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}