pregabalin

Generic: pregabalin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8197
Product ID 63629-8197_a6720b7a-bbe2-4585-9aec-d43df8f54165
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208677
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 636298197
Hyphenated Format 63629-8197

Supplemental Identifiers

RxCUI
483438
UNII
55JG375S6M

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
  • 30 CAPSULE in 1 BOTTLE (63629-8197-1)
  • 90 CAPSULE in 1 BOTTLE (63629-8197-2)
  • 60 CAPSULE in 1 BOTTLE (63629-8197-3)
source: ndc

Packages (3)

63629-8197-1 30 CAPSULE in 1 BOTTLE (63629-8197-1) 63629-8197-2 90 CAPSULE in 1 BOTTLE (63629-8197-2) 63629-8197-3 60 CAPSULE in 1 BOTTLE (63629-8197-3)

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": "a6720b7a-bbe2-4585-9aec-d43df8f54165", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438"], "spl_set_id": ["fd568ede-dac7-4910-bb18-65fb00f2636e"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63629-8197-1)", "package_ndc": "63629-8197-1", "marketing_start_date": "20190801"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (63629-8197-2)", "package_ndc": "63629-8197-2", "marketing_start_date": "20190725"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (63629-8197-3)", "package_ndc": "63629-8197-3", "marketing_start_date": "20190801"}], "brand_name": "Pregabalin", "product_id": "63629-8197_a6720b7a-bbe2-4585-9aec-d43df8f54165", "dosage_form": "CAPSULE", "product_ndc": "63629-8197", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Bryant Ranch Prepack", "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": "20190719", "listing_expiration_date": "20261231"}