pregabalin

Generic: pregabalin

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler direct_rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 75 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-021
Product ID 72189-021_2c4e8635-a2d3-601d-e063-6294a90aaee3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208677
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-07-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189021
Hyphenated Format 72189-021

Supplemental Identifiers

RxCUI
483450
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
  • 75 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (72189-021-30)
  • 60 CAPSULE in 1 BOTTLE (72189-021-60)
  • 90 CAPSULE in 1 BOTTLE (72189-021-90)
source: ndc

Packages (3)

72189-021-30 30 CAPSULE in 1 BOTTLE (72189-021-30) 72189-021-60 60 CAPSULE in 1 BOTTLE (72189-021-60) 72189-021-90 90 CAPSULE in 1 BOTTLE (72189-021-90)

Ingredients (1)

pregabalin (75 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": "2c4e8635-a2d3-601d-e063-6294a90aaee3", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483450"], "spl_set_id": ["8ee9e08f-cf87-599c-e053-2995a90a563c"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72189-021-30)", "package_ndc": "72189-021-30", "marketing_start_date": "20190730"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (72189-021-60)", "package_ndc": "72189-021-60", "marketing_start_date": "20190730"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (72189-021-90)", "package_ndc": "72189-021-90", "marketing_start_date": "20190730"}], "brand_name": "PREGABALIN", "product_id": "72189-021_2c4e8635-a2d3-601d-e063-6294a90aaee3", "dosage_form": "CAPSULE", "product_ndc": "72189-021", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREGABALIN", "active_ingredients": [{"name": "PREGABALIN", "strength": "75 mg/1"}], "application_number": "ANDA208677", "marketing_category": "ANDA", "marketing_start_date": "20190730", "listing_expiration_date": "20261231"}