pregabalin

Generic: pregabalin

Labeler: sciegen pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler sciegen pharmaceuticals, inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 100 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50228-648
Product ID 50228-648_459f0d45-9805-26f8-e063-6394a90a7e6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208677
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-12-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228648
Hyphenated Format 50228-648

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0350228651905 0350288642905 0350228646901
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 ANDA208677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (50228-648-05)
  • 90 CAPSULE in 1 BOTTLE (50228-648-90)
source: ndc

Packages (2)

50228-648-05 500 CAPSULE in 1 BOTTLE (50228-648-05) 50228-648-90 90 CAPSULE in 1 BOTTLE (50228-648-90)

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": "459f0d45-9805-26f8-e063-6394a90a7e6e", "openfda": {"upc": ["0350228651905", "0350288642905", "0350228646901"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["459f0d31-a73f-2c62-e063-6394a90a810c"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (50228-648-05)", "package_ndc": "50228-648-05", "marketing_start_date": "20251210"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (50228-648-90)", "package_ndc": "50228-648-90", "marketing_start_date": "20251210"}], "brand_name": "Pregabalin", "product_id": "50228-648_459f0d45-9805-26f8-e063-6394a90a7e6e", "dosage_form": "CAPSULE", "product_ndc": "50228-648", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "ScieGen Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "100 mg/1"}], "application_number": "ANDA208677", "marketing_category": "ANDA", "marketing_start_date": "20251210", "listing_expiration_date": "20261231"}