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 300 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3646
Product ID 70518-3646_3ff15df4-ae88-575d-e063-6294a90a3d36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207799
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-02-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183646
Hyphenated Format 70518-3646

Supplemental Identifiers

RxCUI
483444
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
  • 300 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3646-0)
source: ndc

Packages (1)

70518-3646-0 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3646-0)

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": "3ff15df4-ae88-575d-e063-6294a90a3d36", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483444"], "spl_set_id": ["9c38abbc-2b3d-48d6-b629-4a163c803db5"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3646-0)", "package_ndc": "70518-3646-0", "marketing_start_date": "20230216"}], "brand_name": "Pregabalin", "product_id": "70518-3646_3ff15df4-ae88-575d-e063-6294a90a3d36", "dosage_form": "CAPSULE", "product_ndc": "70518-3646", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "300 mg/1"}], "application_number": "ANDA207799", "marketing_category": "ANDA", "marketing_start_date": "20230216", "listing_expiration_date": "20261231"}