pregabalin

Generic: pregabalin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 50 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-619
Product ID 71610-619_d2de5bd4-13ac-4b83-8fa2-a75513e408fc
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 71610619
Hyphenated Format 71610-619

Supplemental Identifiers

RxCUI
483440 483448
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
  • 50 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (71610-619-53)
source: ndc

Packages (1)

71610-619-53 60 CAPSULE in 1 BOTTLE (71610-619-53)

Ingredients (1)

pregabalin (50 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": "d2de5bd4-13ac-4b83-8fa2-a75513e408fc", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483440", "483448"], "spl_set_id": ["aa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-619-53)", "package_ndc": "71610-619-53", "marketing_start_date": "20211202"}], "brand_name": "Pregabalin", "product_id": "71610-619_d2de5bd4-13ac-4b83-8fa2-a75513e408fc", "dosage_form": "CAPSULE", "product_ndc": "71610-619", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "50 mg/1"}], "application_number": "ANDA208677", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}