pregabalin

Generic: pregabalin

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pregabalin 165 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-078
Product ID 72205-078_f6aa5977-97c8-4a56-8e35-d9ab5cc24369
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213226
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2021-04-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205078
Hyphenated Format 72205-078

Supplemental Identifiers

RxCUI
1988974 1988977 1988980
UPC
0372205078307 0372205077300 0372205079304
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 ANDA213226 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 165 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-078-30)
source: ndc

Packages (1)

72205-078-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-078-30)

Ingredients (1)

pregabalin (165 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": "f6aa5977-97c8-4a56-8e35-d9ab5cc24369", "openfda": {"upc": ["0372205078307", "0372205077300", "0372205079304"], "unii": ["55JG375S6M"], "rxcui": ["1988974", "1988977", "1988980"], "spl_set_id": ["f6aa5977-97c8-4a56-8e35-d9ab5cc24369"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-078-30)", "package_ndc": "72205-078-30", "marketing_start_date": "20210413"}], "brand_name": "PREGABALIN", "product_id": "72205-078_f6aa5977-97c8-4a56-8e35-d9ab5cc24369", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "72205-078", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREGABALIN", "active_ingredients": [{"name": "PREGABALIN", "strength": "165 mg/1"}], "application_number": "ANDA213226", "marketing_category": "ANDA", "marketing_start_date": "20210413", "listing_expiration_date": "20261231"}