pregabalin

Generic: pregabalin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3643
Product ID 70518-3643_43d05ca9-55c9-c3e9-e063-6394a90a7364
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207799
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-02-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183643
Hyphenated Format 70518-3643

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 ANDA207799 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3643-0)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3643-1)
source: ndc

Packages (2)

70518-3643-0 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3643-0) 70518-3643-1 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3643-1)

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": "43d05ca9-55c9-c3e9-e063-6394a90a7364", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438"], "spl_set_id": ["3c8ea6da-5771-4096-a915-700e51ced05c"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3643-0)", "package_ndc": "70518-3643-0", "marketing_start_date": "20230215"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3643-1)", "package_ndc": "70518-3643-1", "marketing_start_date": "20230215"}], "brand_name": "Pregabalin", "product_id": "70518-3643_43d05ca9-55c9-c3e9-e063-6394a90a7364", "dosage_form": "CAPSULE", "product_ndc": "70518-3643", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "100 mg/1"}], "application_number": "ANDA207799", "marketing_category": "ANDA", "marketing_start_date": "20230215", "listing_expiration_date": "20261231"}