pregabalin

Generic: pregabalin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 300 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-765
Product ID 65862-765_cd328de3-26bc-43fe-8014-6fa3cee7f413
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205321
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-03-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862765
Hyphenated Format 65862-765

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UNII
55JG375S6M

Packaging Origin

Original Packager
true

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
  • 300 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (65862-765-05)
  • 10 BLISTER PACK in 1 CARTON (65862-765-78) / 10 CAPSULE in 1 BLISTER PACK (65862-765-10)
  • 90 CAPSULE in 1 BOTTLE (65862-765-90)
source: ndc

Packages (3)

65862-765-05 500 CAPSULE in 1 BOTTLE (65862-765-05) 65862-765-78 10 BLISTER PACK in 1 CARTON (65862-765-78) / 10 CAPSULE in 1 BLISTER PACK (65862-765-10) 65862-765-90 90 CAPSULE in 1 BOTTLE (65862-765-90)

Ingredients (1)

pregabalin (300 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": "cd328de3-26bc-43fe-8014-6fa3cee7f413", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["11034861-eef2-4996-8082-afc3c1769171"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65862-765-05)", "package_ndc": "65862-765-05", "marketing_start_date": "20230329"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-765-78)  / 10 CAPSULE in 1 BLISTER PACK (65862-765-10)", "package_ndc": "65862-765-78", "marketing_start_date": "20230329"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (65862-765-90)", "package_ndc": "65862-765-90", "marketing_start_date": "20230329"}], "brand_name": "Pregabalin", "product_id": "65862-765_cd328de3-26bc-43fe-8014-6fa3cee7f413", "dosage_form": "CAPSULE", "product_ndc": "65862-765", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "300 mg/1"}], "application_number": "ANDA205321", "marketing_category": "ANDA", "marketing_start_date": "20230329", "listing_expiration_date": "20261231"}