pregabalin

Generic: pregabalin

Labeler: advagen pharma ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler advagen pharma ltd.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pregabalin 82.5 mg/1

Manufacturer
Advagen Pharma Ltd.

Identifiers & Regulatory

Product NDC 72888-049
Product ID 72888-049_49fe33c0-b2ae-e0c1-e063-6294a90a36a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215249
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2022-03-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888049
Hyphenated Format 72888-049

Supplemental Identifiers

RxCUI
1988974 1988977 1988980
UPC
0372888049304 0372888051307 0372888050300
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 ANDA215249 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 82.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-049-30)
source: ndc

Packages (1)

72888-049-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-049-30)

Ingredients (1)

pregabalin (82.5 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": "49fe33c0-b2ae-e0c1-e063-6294a90a36a4", "openfda": {"upc": ["0372888049304", "0372888051307", "0372888050300"], "unii": ["55JG375S6M"], "rxcui": ["1988974", "1988977", "1988980"], "spl_set_id": ["2ffee7e7-bfa0-4933-9baf-7df55080816e"], "manufacturer_name": ["Advagen Pharma Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-049-30)", "package_ndc": "72888-049-30", "marketing_start_date": "20220322"}], "brand_name": "Pregabalin", "product_id": "72888-049_49fe33c0-b2ae-e0c1-e063-6294a90a36a4", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "72888-049", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Advagen Pharma Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "82.5 mg/1"}], "application_number": "ANDA215249", "marketing_category": "ANDA", "marketing_start_date": "20220322", "listing_expiration_date": "20271231"}