pregabalin extended release

Generic: pregabalin

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

Drug Facts

Product Profile

Brand Name pregabalin extended release
Generic Name pregabalin
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pregabalin 82.5 mg/1

Manufacturer
ScieGen Pharmaceuticals, INC.

Identifiers & Regulatory

Product NDC 50228-462
Product ID 50228-462_e90bfe09-9adb-03c0-e053-2a95a90a061e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215675
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2022-09-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228462
Hyphenated Format 50228-462

Supplemental Identifiers

RxCUI
1988974 1988977 1988980
UPC
0350228463300 0350228464055 0350228464307 0350228462303 0350228463058 0350228462051
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 extended release (source: ndc)
Generic Name pregabalin (source: ndc)
Application Number ANDA215675 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 82.5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-30)
source: ndc

Packages (2)

50228-462-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-05) 50228-462-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-30)

Ingredients (1)

pregabalin (82.5 mg/1)

Linked Drug Pages (1)

Pregabalin Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e90bfe09-9adb-03c0-e053-2a95a90a061e", "openfda": {"upc": ["0350228463300", "0350228464055", "0350228464307", "0350228462303", "0350228463058", "0350228462051"], "unii": ["55JG375S6M"], "rxcui": ["1988974", "1988977", "1988980"], "spl_set_id": ["1544a657-353c-47f8-96ac-a63fa78373f0"], "manufacturer_name": ["ScieGen Pharmaceuticals, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-05)", "package_ndc": "50228-462-05", "marketing_start_date": "20220914"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-30)", "package_ndc": "50228-462-30", "marketing_start_date": "20220914"}], "brand_name": "Pregabalin Extended Release", "product_id": "50228-462_e90bfe09-9adb-03c0-e053-2a95a90a061e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "50228-462", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "ScieGen Pharmaceuticals, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin Extended Release", "active_ingredients": [{"name": "PREGABALIN", "strength": "82.5 mg/1"}], "application_number": "ANDA215675", "marketing_category": "ANDA", "marketing_start_date": "20220914", "listing_expiration_date": "20261231"}