pregabalin

Generic: pregabalin

Labeler: tris pharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler tris pharma inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 50 mg/1

Manufacturer
Tris Pharma Inc

Identifiers & Regulatory

Product NDC 27808-235
Product ID 27808-235_34723420-dabe-4070-83f1-5de1db603532
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214322
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2021-07-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808235
Hyphenated Format 27808-235

Supplemental Identifiers

RxCUI
483438 483440 483444 483446 483448 483450 577127
UPC
0327808239013 0327808237019 0327808241016 0327808236012 0327808240019 0327808235015 0327808238016
UNII
55JG375S6M

Packaging Origin

Original Packager
true

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 ANDA214322 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (27808-235-01)
source: ndc

Packages (1)

27808-235-01 90 CAPSULE in 1 BOTTLE (27808-235-01)

Ingredients (1)

pregabalin (50 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": "34723420-dabe-4070-83f1-5de1db603532", "openfda": {"upc": ["0327808239013", "0327808237019", "0327808241016", "0327808236012", "0327808240019", "0327808235015", "0327808238016"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["62aa850d-199c-44d5-a730-45f43efa850e"], "manufacturer_name": ["Tris Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (27808-235-01)", "package_ndc": "27808-235-01", "marketing_start_date": "20220201"}], "brand_name": "Pregabalin", "product_id": "27808-235_34723420-dabe-4070-83f1-5de1db603532", "dosage_form": "CAPSULE", "product_ndc": "27808-235", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Tris Pharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "50 mg/1"}], "application_number": "ANDA214322", "marketing_category": "ANDA", "marketing_start_date": "20210715", "listing_expiration_date": "20261231"}