pregabalin

Generic: pregabalin

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 150 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0397
Product ID 80425-0397_1a280b06-dc3b-3735-e063-6394a90ab02b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208677
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-06-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250397
Hyphenated Format 80425-0397

Supplemental Identifiers

RxCUI
483440 577127
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
  • 150 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (80425-0397-1)
  • 60 CAPSULE in 1 BOTTLE (80425-0397-2)
  • 90 CAPSULE in 1 BOTTLE (80425-0397-3)
source: ndc

Packages (3)

80425-0397-1 30 CAPSULE in 1 BOTTLE (80425-0397-1) 80425-0397-2 60 CAPSULE in 1 BOTTLE (80425-0397-2) 80425-0397-3 90 CAPSULE in 1 BOTTLE (80425-0397-3)

Ingredients (1)

pregabalin (150 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": "1a280b06-dc3b-3735-e063-6394a90ab02b", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483440", "577127"], "spl_set_id": ["1a15cd11-0db9-2bc8-e063-6394a90a11fb"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0397-1)", "package_ndc": "80425-0397-1", "marketing_start_date": "20240604"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (80425-0397-2)", "package_ndc": "80425-0397-2", "marketing_start_date": "20240604"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (80425-0397-3)", "package_ndc": "80425-0397-3", "marketing_start_date": "20240604"}], "brand_name": "Pregabalin", "product_id": "80425-0397_1a280b06-dc3b-3735-e063-6394a90ab02b", "dosage_form": "CAPSULE", "product_ndc": "80425-0397", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "150 mg/1"}], "application_number": "ANDA208677", "marketing_category": "ANDA", "marketing_start_date": "20240604", "listing_expiration_date": "20261231"}