pregablin

Generic: pregablin

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregablin
Generic Name pregablin
Labeler macleods pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 100 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-168
Product ID 33342-168_cb84edec-54d3-4100-99d9-b513cc6cbf1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205924
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-11-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342168
Hyphenated Format 33342-168

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0333342168108 0333342166104 0333342165107 0333342172105 0333342169105 0333342167101 0333342170101
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 pregablin (source: ndc)
Generic Name pregablin (source: ndc)
Application Number ANDA205924 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (33342-168-10)
source: ndc

Packages (1)

33342-168-10 90 CAPSULE in 1 BOTTLE (33342-168-10)

Ingredients (1)

pregabalin (100 mg/1)

Linked Drug Pages (1)

Pregablin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cb84edec-54d3-4100-99d9-b513cc6cbf1e", "openfda": {"upc": ["0333342168108", "0333342166104", "0333342165107", "0333342172105", "0333342169105", "0333342167101", "0333342170101"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["a3a94949-3060-4057-9b29-e06a808cbd76"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (33342-168-10)", "package_ndc": "33342-168-10", "marketing_start_date": "20241113"}], "brand_name": "Pregablin", "product_id": "33342-168_cb84edec-54d3-4100-99d9-b513cc6cbf1e", "dosage_form": "CAPSULE", "product_ndc": "33342-168", "dea_schedule": "CV", "generic_name": "Pregablin", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregablin", "active_ingredients": [{"name": "PREGABALIN", "strength": "100 mg/1"}], "application_number": "ANDA205924", "marketing_category": "ANDA", "marketing_start_date": "20241113", "listing_expiration_date": "20261231"}