pregabalin

Generic: pregabalin

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

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler exelan pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 225 mg/1

Manufacturer
Exelan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 76282-574
Product ID 76282-574_b26b72af-62e4-4eb5-9cb8-e4eb05a22435
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211384
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-07-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282574
Hyphenated Format 76282-574

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0376282569901 0376282571904 0376282570907 0376282572901 0376282568904 0376282575902 0376282574905 0376282573908
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 ANDA211384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (76282-574-05)
  • 90 CAPSULE in 1 BOTTLE (76282-574-90)
source: ndc

Packages (2)

76282-574-05 500 CAPSULE in 1 BOTTLE (76282-574-05) 76282-574-90 90 CAPSULE in 1 BOTTLE (76282-574-90)

Ingredients (1)

pregabalin (225 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": "b26b72af-62e4-4eb5-9cb8-e4eb05a22435", "openfda": {"upc": ["0376282569901", "0376282571904", "0376282570907", "0376282572901", "0376282568904", "0376282575902", "0376282574905", "0376282573908"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["3fdc6e94-2504-416c-81dd-2db9bc194ebb"], "manufacturer_name": ["Exelan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (76282-574-05)", "package_ndc": "76282-574-05", "marketing_start_date": "20190719"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76282-574-90)", "package_ndc": "76282-574-90", "marketing_start_date": "20190719"}], "brand_name": "Pregabalin", "product_id": "76282-574_b26b72af-62e4-4eb5-9cb8-e4eb05a22435", "dosage_form": "CAPSULE", "product_ndc": "76282-574", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Exelan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "225 mg/1"}], "application_number": "ANDA211384", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}