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 200 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2763
Product ID 70518-2763_4a8ec75e-3221-744d-e063-6394a90a3846
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209357
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2020-06-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705182763
Hyphenated Format 70518-2763

Supplemental Identifiers

RxCUI
483446
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 ANDA209357 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (70518-2763-1)
source: ndc

Packages (1)

70518-2763-1 30 CAPSULE in 1 BLISTER PACK (70518-2763-1)

Ingredients (1)

pregabalin (200 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": "4a8ec75e-3221-744d-e063-6394a90a3846", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483446"], "spl_set_id": ["91edbe87-cd22-43a5-9952-1cd523b13820"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-2763-1)", "package_ndc": "70518-2763-1", "marketing_start_date": "20230310"}], "brand_name": "Pregabalin", "product_id": "70518-2763_4a8ec75e-3221-744d-e063-6394a90a3846", "dosage_form": "CAPSULE", "product_ndc": "70518-2763", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "200 mg/1"}], "application_number": "ANDA209357", "marketing_category": "ANDA", "marketing_start_date": "20200604", "listing_expiration_date": "20271231"}