pregabalin

Generic: pregabalin

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler solco healthcare us, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 300 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-513
Product ID 43547-513_e7ff85eb-a068-40a7-88f0-4fa6abf6375e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207883
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2020-06-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547513
Hyphenated Format 43547-513

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0343547507091 0343547513092 0343547506094 0343547508098 0343547509095
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 ANDA207883 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (43547-513-09)
  • 500 CAPSULE in 1 BOTTLE (43547-513-50)
source: ndc

Packages (2)

43547-513-09 90 CAPSULE in 1 BOTTLE (43547-513-09) 43547-513-50 500 CAPSULE in 1 BOTTLE (43547-513-50)

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": "e7ff85eb-a068-40a7-88f0-4fa6abf6375e", "openfda": {"upc": ["0343547507091", "0343547513092", "0343547506094", "0343547508098", "0343547509095"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["085db834-3735-40d9-ac67-f9dbb82390c5"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (43547-513-09)", "package_ndc": "43547-513-09", "marketing_start_date": "20200615"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (43547-513-50)", "package_ndc": "43547-513-50", "marketing_start_date": "20200615"}], "brand_name": "PREGABALIN", "product_id": "43547-513_e7ff85eb-a068-40a7-88f0-4fa6abf6375e", "dosage_form": "CAPSULE", "product_ndc": "43547-513", "dea_schedule": "CV", "generic_name": "pregabalin", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREGABALIN", "active_ingredients": [{"name": "PREGABALIN", "strength": "300 mg/1"}], "application_number": "ANDA207883", "marketing_category": "ANDA", "marketing_start_date": "20200615", "listing_expiration_date": "20261231"}