pregabalin

Generic: pregabalin

Labeler: marksans pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler marksans pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 300 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-186
Product ID 25000-186_b8d46cc7-2959-411f-839c-eced90c38e92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216197
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000186
Hyphenated Format 25000-186

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
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 ANDA216197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (25000-186-07)
source: ndc

Packages (1)

25000-186-07 90 CAPSULE in 1 BOTTLE (25000-186-07)

Ingredients (1)

pregabalin (300 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": "b8d46cc7-2959-411f-839c-eced90c38e92", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["b2b81bb6-5423-4221-8a61-f70a38d6a1e9"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (25000-186-07)", "package_ndc": "25000-186-07", "marketing_start_date": "20220801"}], "brand_name": "Pregabalin", "product_id": "25000-186_b8d46cc7-2959-411f-839c-eced90c38e92", "dosage_form": "CAPSULE", "product_ndc": "25000-186", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "300 mg/1"}], "application_number": "ANDA216197", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}