pregabalin

Generic: pregabalin

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pregabalin 100 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1628
Product ID 67046-1628_486f605f-c7f0-6140-e063-6394a90ab77f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205321
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2025-12-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461628
Hyphenated Format 67046-1628

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 ANDA205321 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (67046-1628-3)
source: ndc

Packages (1)

67046-1628-3 30 CAPSULE in 1 BLISTER PACK (67046-1628-3)

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": "486f605f-c7f0-6140-e063-6394a90ab77f", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438"], "spl_set_id": ["463d31dd-ff14-cc89-e063-6294a90a2ea9"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (67046-1628-3)", "package_ndc": "67046-1628-3", "marketing_start_date": "20251218"}], "brand_name": "Pregabalin", "product_id": "67046-1628_486f605f-c7f0-6140-e063-6394a90ab77f", "dosage_form": "CAPSULE", "product_ndc": "67046-1628", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "100 mg/1"}], "application_number": "ANDA205321", "marketing_category": "ANDA", "marketing_start_date": "20251218", "listing_expiration_date": "20271231"}